CMV IgM EIA — Class II medical device recall Z-0342-2023
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2022-12-07, distributed in CA, CO, FL, GA, HI, IA, MA, MN…. Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Im
| Recall number | Z-0342-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Redmond, WA, United States |
| Recall initiated | 2022-10-19 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Distributed | CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, TX |
| Quantity | 180 kits |
| UPC / GTIN / UDI-DI | 00847865010733 |
| Lot numbers | B02022, E10022, G05022 |
| Model numbers | 25178 |
Product
CMV IgM EIA, in vitro diagnostic.
Reason for recall
Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0342-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.