Device product
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436
Z-0836-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 310 units
- Official record key
device-enforcement:Z-0836-2023
Official wording
Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Code information: UDI/DI 03573026399016, Batch Numbers: 5992201403, 5992253503
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As the temperature and time out of range was exceeded, product performances cannot be guaranteed