Device product
PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100
Z-0870-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0870-2023
Official wording
Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Code information: UDI/DI 03661901005531, Batch Numbers: 2134340
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As the temperature and time out of range was exceeded, product performances cannot be guaranteed