Class II — Bio-Rad Laboratories, Inc.
| Recalling firm | Bio-Rad Laboratories (Bio-Rad Services France) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). |
| Product | CMV IgM EIA, in vitro diagnostic. |
| Quantity | 180 kits |
| Distribution | U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None |
| Initiated | 2022-10-19 |
| Classified | 2022-11-30 |
| Recall number | Z-0342-2023 |
| 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 — Bio-Rad Laboratories, Inc. (Z-0342-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91106/
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