Class II — bioMerieux, Inc.
| Recalling firm | BIOMERIEUX SA |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | False Positive ESBL Phenotype |
| Product | VITEK 2 AST-N351 Test Kit |
| Quantity | 30,292 cartons (20 cards per carton) |
| Distribution | UK and Ireland |
| Initiated | 2018-12-13 |
| Classified | 2019-02-16 |
| Terminated | 2021-08-16 |
| Recall number | Z-0847-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — bioMerieux, Inc. (Z-0847-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81953/
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