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 integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency). |
| Product | VITEK® 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton. |
| Quantity | 463 cartons |
| Distribution | Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch… |
| Initiated | 2017-04-20 |
| Classified | 2017-06-13 |
| Terminated | 2020-07-22 |
| Recall number | Z-2454-2017 |
| 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-2454-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77026/
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