Recall Z-0243-2022— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2021-09-30, terminated 2024-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: API 50 CH, Model 50300. Reason: There is potential to provide an incorrect organism identification..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-09-30
- Terminated
- 2024-01-18
- Firm location
- Durham, NC, United States
Product description
API 50 CH, Model 50300
Reason for recall
There is potential to provide an incorrect organism identification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.