BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack — Class II medical device recall Z-1096-2022
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2022-05-25, distributed nationwide. Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending
| Recall number | Z-1096-2022 |
|---|---|
| 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 | 2022-04-14 |
| Classified | 2022-05-16 |
| Reported by FDA | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, DE, FR, IT |
| Quantity | 348 units |
| UPC / GTIN / UDI-DI | 03610520992715 |
| Lot numbers | 301388 |
| Model numbers | 12000670 |
Product
BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Reason for recall
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
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-1096-2022. 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.