Radiometer ABL800 FLEX Series

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

• Radiometer ABL800 Flex Reference ManualUser Manual · External
• Radiometer ABL800 Operators ManualUser Manual · External
• Radiometer ABL800 Flex BrochureBrochure · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The analyzer software includes a feature (watchdog) that detects a freeze and automatically restarts the software to continue operating the analyzer. However, even if a restart occurs, any sample being processed at that time will be lost, potential to lead to delay in test results.

• RECALL

  Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.

• RECALL

  There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.

• RECALL

  Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

• RECALL

  Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.

• RECALL

  Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment

• RECALL

  Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.

• RECALL

  The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. This could result is patient mixup and/or lost of sample, resulting in delayed medical treatment.

• RECALL

  The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.

• RECALL

  Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.

• RECALL

  The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.

• RECALL

  From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situ

• RECALL

  The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the inlet and quickly closes it again

• RECALL

  Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.

• RECALL

  Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

• RECALL

  The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

• RECALL

  Negative drift on QC during in-use lifetime of CREA membranes can be observed.

• RECALL

  RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

• RECALL

  RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.

• RECALL

  A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t

• RECALL

  When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for dissolving the additive. This will cause the concentration of creatinin and creatin in the calibration solution to be wrong, and results in a bias on the Crea results.

• RECALL

  Transcutaneous pCO2-electrodes were wrongly coded as: pO2 electrode on the hardware plug for the firm's TCM series monitors. This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.

• RECALL

  Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias resulting in calcium measuring errors. This situation poses a risk to the safety of patients, particularly when the measurement results are used

• RECALL

  Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. If the device operator/user ignores the error message and continues to obtain biased measuring results using the

• RECALL

  Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.

• RECALL

  Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.

• RECALL

  Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results.

• RECALL

  Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.

• RECALL

  In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

• RECALL

  Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. This condition can influence analyzer results. When the protein removal program is run too frequently, more than once a week, or when running the protein rem

• RECALL

  Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases RADIANCE will transmit the original FI02 value, not the value that was edited.

• RECALL

  System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.

• RECALL

  ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.

• RECALL

  Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.

• RECALL

  Under certain circumstances, the ABL 700 & 800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and Sodium (Na).

• RECALL

  Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase.

• RECALL

  QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.