BioPlex 2200 REF 665-2050 — Class II medical device recall Z-1572-2023
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2023-05-17, distributed nationwide. APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-pos
| Recall number | Z-1572-2023 |
|---|---|
| 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 | 2023-02-28 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 932 reagent |
| UPC / GTIN / UDI-DI | 00847865000666 |
| Lot numbers | 301538 |
| Model numbers | 665-2050 |
Product
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Reason for recall
APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
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-1572-2023. 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.