BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR… — Class II medical device recall Z-0235-2022
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2021-11-24, distributed nationwide. Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reac
| Recall number | Z-0235-2022 |
|---|---|
| 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 | 2021-09-17 |
| Classified | 2021-11-16 |
| Reported by FDA | 2021-11-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, FR, IL, IT, TW, ZA |
| Quantity | 11,610 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 03610520653012 |
| Lot numbers | 301210 |
| Model numbers | 12000650 |
Product
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
Reason for recall
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
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-0235-2022. 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.