BioPlex 2200 — Class II medical device recall Z-1377-2023
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2023-04-19, distributed nationwide. Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 3014
| Recall number | Z-1377-2023 |
|---|---|
| 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 | 2023-02-21 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CZ, DE, ES, FR, GB, IL, IT, NO, SE |
| Quantity | 1,544 units |
| UPC / GTIN / UDI-DI | 00847865000857 |
| Lot numbers | 301481 |
| Model numbers | 665-3250 |
Product
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Reason for recall
Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.
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-1377-2023. 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.