Drug recall
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent…
FDA recall event 82501 · Class II · bioMerieux, Inc.
Key facts
| Event ID | 82501 |
|---|---|
| Recall numbers | Z-1137-2019 |
| Recalling firm | bioMerieux, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 15, 2019 |
| Report date | Apr 24, 2019 |
| Termination date | Aug 17, 2021 |
| City | Durham |
| State | NC |
| Country | United States |
| FEI number | 3002769706 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: