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 | Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result. |
| Product | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit |
| Quantity | 1,218 US units total (726 US, 492 OUS) |
| Distribution | Distributed nationwide and 9 units to Biomerieux Canada. |
| Initiated | 2019-12-10 |
| Classified | 2020-02-07 |
| Terminated | 2021-02-16 |
| Recall number | Z-1107-2020 |
| 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-1107-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84439/
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