Device product
PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
Z-0871-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 60 units
- Official record key
device-enforcement:Z-0871-2023
Official wording
Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Code information: UDI/DI 03573026319946, Batch Numbers: 1009524320
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As the temperature and time out of range was exceeded, product performances cannot be guaranteed