Class III — 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 III |
| Status | Terminated |
| Reason | The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. |
| Product | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae. |
| Quantity | 2053 cartons |
| Distribution | Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution. |
| Initiated | 2015-02-25 |
| Classified | 2015-04-08 |
| Terminated | 2017-03-22 |
| Recall number | Z-1402-2015 |
| 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 III recall — Biomerieux Inc (Z-1402-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70645/
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