Device product
VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.
Z-0653-2019
Product summary
- Event
- Event 81563
- Status
- Terminated
- Classification
- Class II
- Quantity
- 728
- Official record key
device-enforcement:Z-0653-2019
Official wording
Reason: Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Code information: Product Code: 6802445 UDI: 10758750012343 Serial Numbers: J46000108-J46001132
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
Software anomaly