Device product
API 50 CH, Model 50300
Z-0243-2022
Product summary
- Firm
- bioMerieux, Inc.
- Event
- Event 88844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1382 kits
- Official record key
device-enforcement:Z-0243-2022
Official wording
Reason: There is potential to provide an incorrect organism identification.
Code information: Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
Distribution pattern: Distribution in WI, NY, and SD
Derived failure modes
-
Unknown
There is potential to provide an incorrect organism identification.