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 product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. |
| Product | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. |
| Quantity | 4/20-card cartons |
| Distribution | Distributed only in HI. |
| Initiated | 2013-02-06 |
| Classified | 2013-03-27 |
| Terminated | 2013-10-30 |
| Recall number | Z-1013-2013 |
| 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-1013-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64327/
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