Device product
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Z-0812-2023
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 91148
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0812-2023
Official wording
Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Code information: UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
As the temperature and time out of range was exceeded, product performances cannot be guaranteed