FDA recall Z-0243-2022
bioMerieux, Inc. · Class II · device
Product
API 50 CH, Model 50300
Reason for recall
There is potential to provide an incorrect organism identification.
Distribution
Distribution in WI, NY, and SD
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-30
- Report date
- 2021-11-24
- Termination date
- 2024-01-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Durham, NC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0243-2022