Device product
VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
Z-0856-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-0856-2023
Official wording
Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Code information: UDI/DI 03573026618834, Batch Numbers: 412148504
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As the temperature and time out of range was exceeded, product performances cannot be guaranteed