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 | The VITEK® 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK® 2 FLEXPREP" feature. |
| Product | VITEK® 2 Systems Software Version 9.01 Update Kit. |
| Quantity | five (5) VITEK® 2 Systems Software version 9.01 |
| Distribution | Nationwide distribution to CO, IL, MO, TX. |
| Initiated | 2018-11-13 |
| Classified | 2018-12-19 |
| Terminated | 2021-07-07 |
| Recall number | Z-0639-2019 |
| 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-0639-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81589/
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