CELL-DYN

Technical Specs

MRI safety

Labeling does not contain MRI Safety Information

Sterile

No

Single use

No

Prescription use

Rx only

FDA distribution status

In Commercial Distribution

Device type (GMDN)

Haematological cell analyser IVD

FDA product classification

Counter, differential cell

Manufacturer support

+1(877)422-2688 · xx@xx.xx

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

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

• RECALL

  The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

• RECALL

  The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner and outer surfaces which may result in falsely elevated platelet results.

• RECALL

  There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

• RECALL

  The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage

• RECALL

  Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.

• RECALL

  The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

• RECALL

  There is the potential for the instrument to not power up due to the flash memory issue. This will result in an error message displayed is "No Memory Available" and has the potential for delay in generating patient results.

• RECALL

  The product bar code label, when scanned, indicates that the volume is 10 mL rather than the correct volume of 10,000 mL. Analytical results are not impacted, although, there is a potential for delay in generating results.

• RECALL

  Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.

• RECALL

  Under certain conditions in closed mode of operations, the Aspiration Probe Detector PCB assembly may fail to operate properly and provide inaccurate results.

• RECALL

  Abbott has determined that gain settings for the non-standard specimen types may not match the gain settings for the standard specimen type. There is the potential for impact to product performance.

• RECALL

  A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.

• RECALL

  The use of the device assemblies has been extended to a 6 month useful life.

• RECALL

  Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.

• RECALL

  Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.

• RECALL

  FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.

• RECALL

  Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit ). If the customer touches the motor, burns may occur.

• RECALL

  Some syringes were improperly assembled and are therefore not usable, due to an incorrect nut on the syringe shell.

• RECALL

  Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.

• RECALL

  Exposed wire resulted in minor electrical shock and burn to the service technician

• RECALL

  Table in LIS Specification depicting the association between Record ID and Numerical Result Label is incorrect. If a record ID is used to configure the system for mapping, results will come out nonsensical.

• RECALL

  Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.

• RECALL

  Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

• RECALL

  Syringe Failure: Insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter

• RECALL

  Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)

• RECALL

  The product failed electrostatic discharge testing, which could result in product failure.

• RECALL

  Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.

• RECALL

  Incorrect Results: Hemoglobin results in donor samples assayed on the CELL-DYN 1800 System vary more than expected across the range of claimed operating temperatures of 18 degrees Celcius to 30 degrees Celcius.

• RECALL

  Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

• RECALL

  High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

• RECALL

  T-Cell test results and the respective absolute counts for the CELL-DYN Sapphire instrument using CD3/4/8 reagents can be overestimated by as much as 13%.

• RECALL

  The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.

• RECALL

  Elevated platelet background count results-some products may show a higher than expected platelet background count when used on the CELL-DYN 3200 System and report patient results that are unacceptable-out-of-range

• RECALL

  Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

• RECALL

  Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

• RECALL

  Product may elicit fluorescent signal interference due to bacterial contamination.

• RECALL

  Product elicits fluorescent signal interference due to contamination.