BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set… — Class II medical device recall Z-0236-2022
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-0236-2022 |
|---|---|
| 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 | 791 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 03610520652770 |
| Lot numbers | 52953 |
| Model numbers | 12000651 |
Product
BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
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-0236-2022. 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.