Beckman Coulter Access 2

Technical Specs

Height

18.5 in

Length

39 in

Weight

200 lbs

Width

24 in

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Central / core laboratory
• Point-of-care testing stations
• Blood bank
• Microbiology lab

Documents & Manuals

• Access Reference ManualUser Manual · External
• Access 2Document · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.

• RECALL

  It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

• RECALL

  Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.

• RECALL

  Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.

• RECALL

  Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

• RECALL

  A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

• RECALL

  A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

• RECALL

  When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

• RECALL

  Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.

• RECALL

  Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.

• RECALL

  Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.

• RECALL

  the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

• RECALL

  Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.

• RECALL

  Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.

• RECALL

  Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.

• RECALL

  Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.

• RECALL

  The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

• RECALL

  The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.

• RECALL

  The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.

• RECALL

  IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

• RECALL

  Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

• RECALL

  Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

• RECALL

  Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

• RECALL

  The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.

• RECALL

  The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

• RECALL

  When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

• RECALL

  When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

• RECALL

  Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator ma

• RECALL

  Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

• RECALL

  The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and

• RECALL

  Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

• RECALL

  On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substrate (81906) lots: 234600, 337984, 338040, 338214, 338229, 338289, 338322, 338333, 338451, 338587, and 338538. Beckman Coulter has identified that Access Substrate bottles in the identified lots were released from manufacturing without labels. Missing label may cause some patient results reporting delay but will not cause any errorreous results. However, because labs are required to have redundancy such that delay would not significantly impact clinical management and because the defect is easily recognized by the user, the probability of harm is remote.

• RECALL

  A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

• RECALL

  There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of IU/mL to the International System of Units (SI units) of pmol/L.

• RECALL

  The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.

• RECALL

  It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.

• RECALL

  Reagent lot numbers include an insufficient concentration of blocking reagent.

• RECALL

  The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient no

• RECALL

  An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm's specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.

• RECALL

  Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.

• RECALL

  Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

• RECALL

  SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

• RECALL

  SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

• RECALL

  specimens collected in transport media may result is false negative results when stored in certain conditions.

• RECALL

  The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

• RECALL

  Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

• RECALL

  Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).

• RECALL

  Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

• RECALL

  The Access immunoassays are susceptible to biotin interference.

• RECALL

  Following biases observed in the results of the French National Quality Controls, Beckman Coulter has been informed that a study completed by the French Competent Authority Agence nationale de scurit du Medicament et des produits de sant (ANSM) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (URL) of 31.3 U/mL as stated in the Access BR Monitor instructions for use (IFU).

• RECALL

  Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

• RECALL

  Beckman Coulter is recalling the Access 2 Family of Immunoassay Systems because a circuit board that controls motor functions can affect device positioning on the pipettor and incubator belt while the instrument is running. The position errors cause the instrument to stop running and cancel tests that are in process.

• RECALL

  Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.

• RECALL

  Demonstrate an upward shift in patient results.

• RECALL

  Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of patient results.

• RECALL

  Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.

• RECALL

  Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.

• RECALL

  Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.

• RECALL

  Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a "MFC Exception" error during normal operation of the Access 2 Immunoassay Systems.

• RECALL

  The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.

• RECALL

  Beckman Coulter is initiating a recall for the Access Immunoassay Systems Reaction Vessels, including the Acess/Access 2 Immunoassay Systems, SYNCRON LXi 725 Clinical System, and UniCel DxC 600i SYNCHRON Access Clinical System because Beckman Coulter has observed an intermittent increase in Access System "Wash Carousel Motion Errors" with specific lots of Access System Reaction Vessels (RVs). I

• RECALL

  Beckman Coulter is recalling the Access 2 Immunoassay System because they determined that the fuses in the system may be of the wrong amperage.

• RECALL

  Beckman Coulter is initiating a recall due to a defective newly released aluminum incubator belt pulley that may rub against the light shield, which causes the formation of debris. Debris that is caused by the incubator belt pulley rubbing against the light shield can fall into the reaction vessels (RVs) and present a risk of erroneous test results.

• RECALL

  Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif

• RECALL

  Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

• RECALL

  The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.

• RECALL

  A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent.

• RECALL

  A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.

• RECALL

  A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.

• RECALL

  The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.

• RECALL

  The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio

• RECALL

  The recall was initiated because certain Access immunoassays can produce inaccurate results when performed within the published UniCel DxI Immunoassay Systems* room temperature operating specification of 18 degrees C to 32 degrees C (64.4 degrees F to 89.6 degrees F). An increase in room temperature causes assay results for some assays to decrease, while results for other assays increase with an i

• RECALL

  The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal reference range) could mask hyperthyroidism. Failure to diagnose or treat hyperthyroid disease associated with pregnancy could result in serious, permanent harm

• RECALL

  The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin Antibody II (TgAbII) reagent lots may produce: (1) Erroneously high TgAb results for both quality co

• RECALL

  The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment.

• RECALL

  Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factors and are particularly noted at the low end of the analytical measuring range. The role of preanalytical factors in laboratory testing has been described in a variety of published literature.

• RECALL

  The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable range of the assay. When customers interchange between diluents there is an unacceptable shift in results. A median difference of 16% (ranging from 14% to 23%) b

• RECALL

  The recall was initiated because Beckman Coulter confirmed Access waste bottles that ruptured and expelled liquid waste, exposing the operator to the system liquid waste. Over time, waste bottles can degrade, become brittle and potentially crack.

• RECALL

  The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.

• RECALL

  This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.

• RECALL

  The recall was initiated because the Instruction for Use (IFU) for Access SHBG does not specify the units of measure to be used when calculating the Free Androgen Index (FAI %). Access SHBG (nmol/L) values and Access Testosterone (ng/mL) values are reported in different default units. The testosterone value (when reported in ng/mL) requires conversion to nmol/L before the FAI % can be calculated.

• RECALL

  The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.

• RECALL

  The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established refere

• RECALL

  The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.

• RECALL

  The recall was initiated because as a follow up to PCA # 12605 dated December 16, 2009, Beckman Coulter has confirmed additional reports that each of the following assays may produce lower than expected results when run in conjunction with Access AccuTnl (REF A78803): (1) Access Testosterone (REF 33560); (2) Access Thyroid Uptake (REF 33810); (3) Access Total T4 (REF 33800). This issue can occ

• RECALL

  The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.

• RECALL

  The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I

• RECALL

  The recall was initiated because Beckman Coulter has confirmed customer reports that different results have been obtained using the same patient samples on Access/Access 2 and UniCel Dxl platforms. Values obtained with UniCel Dxl systems have been demonstrated to have a positive bias compared to values obtained with Access or Access 2 systems.

• RECALL

  Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.

• RECALL

  The recall was initiated after Beckman Coulter confirmed that under certain circumstances, the following assays may produce elevated values at the low end when run in conjunction with the enhanced Access Accu Tnl assay (P/N A 78033): (1) Access Total BhCG (P/N 33500); (2) Access HYPERsensitive hTSH/Fast hTSH (P/N 33820); (3) Access hFSH (P/N 33520). The issue can occur only when the assays are

• RECALL

  The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.

• RECALL

  The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.

• RECALL

  The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.

• RECALL

  The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision.

• RECALL

  Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.

• RECALL

  Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.

• RECALL

  Electrical grounding failure: During manufacturing, internal testing found one instrument wlth an intermittent failure of the electrical grounding. The source of the problem was traced to inadequate soldering.

• RECALL

  Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes

• RECALL

  False negative results when used to test serum samples (as compared to plasma samples).

• RECALL

  Erroneous Results - UniCel Dxl Access Immunoassay Systems Reaction Vessels have been found to be defective and there is a potential for an increase in signal leading to an erroneous result.

• RECALL

  Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

• RECALL

  Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.

• RECALL

  Pipetting for dil-Alpha-fetoprotein when performed on the Access, Access 2 and Synchron LX i 725 has a potential to create splashing which may cause erroneous results.

• RECALL

  Variability in results on Patient and QC results of 20-25%, high and low.

• RECALL

  A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.

• RECALL

  Defective software media distributed with upgrade software may cause installation failure and systems lock.

• RECALL

  Short volume, resulting possibility of falsely elevated results.

• RECALL

  False results from secondary pour off tubes

• RECALL

  Spring failure, design defect in component.

• RECALL

  Primary tube sampling issue may cause false low results.