Z-0243-2022 Class II Terminated
FDA device recall Z-0243-2022 was initiated by bioMerieux, Inc. on September 30, 2021 and is designated Class II. Reason for recall: There is potential to provide an incorrect organism identification. The recall status is terminated (terminated January 18, 2024). Affected quantity: 1382 kits.
Recall Details
- Product Type
- Devices
- Report Date
- November 24, 2021
- Initiation Date
- September 30, 2021
- Termination Date
- January 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1382 kits
Product Description
API 50 CH, Model 50300
Reason for Recall
There is potential to provide an incorrect organism identification.
Distribution Pattern
Distribution in WI, NY, and SD
Code Information
Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230