Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting… — Class II medical device recall Z-1137-2019
Terminated recall by bioMerieux, Inc., reported 2019-04-24. Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strai
| Recall number | Z-1137-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2019-03-15 |
| Classified | 2019-04-12 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2021-08-17 |
| Countries outside the US | DE, GB, LV, PL, UA |
| Quantity | 10,784 cartons |
| UPC / GTIN / UDI-DI | 03573026404550, 03573026474836, 03573026604363 |
| Model numbers | 413723 |
Product
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Reason for recall
Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.413723,418674, 422024) test kits.
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-1137-2019. 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.