Z-0653-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- October 19, 2018
- Termination Date
- January 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 728
Product Description
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.
Reason for Recall
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Distribution Pattern
US Nationwide Distribution
Code Information
Product Code: 6802445 UDI: 10758750012343 Serial Numbers: J46000108-J46001132