Recall Z-0847-2019— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2018-12-13, terminated 2021-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: VITEK 2 AST-N351 Test Kit. Reason: False Positive ESBL Phenotype.
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-13
- Terminated
- 2021-08-16
- Firm location
- Durham, NC, United States
Product description
VITEK 2 AST-N351 Test Kit
Reason for recall
False Positive ESBL Phenotype
Data sourced from openFDA. This site is unofficial and independent of the FDA.