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 | Invalid calibrations (out of range high) while using the product. |
| Product | VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. |
| Quantity | 480 kits |
| Distribution | Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH, PA, TX, VA, WI, and WV. There was government distribution but no military or foreign distribution. |
| Initiated | 2022-02-09 |
| Classified | 2022-03-14 |
| Terminated | 2026-04-01 |
| Recall number | Z-0742-2022 |
| 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-0742-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89568/
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