VITEK 2 AST-N351 Test Kit — Class II medical device recall Z-0847-2019
Terminated recall by bioMerieux, Inc., reported 2019-02-27. False Positive ESBL Phenotype
| Recall number | Z-0847-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2018-12-13 |
| Classified | 2019-02-16 |
| Reported by FDA | 2019-02-27 |
| Terminated | 2021-08-16 |
| Countries outside the US | GB, IE |
| Model numbers | 421257 |
Product
VITEK 2 AST-N351 Test Kit
Reason for recall
False Positive ESBL Phenotype
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0847-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.