BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent… — Class II medical device recall Z-0806-2022
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2022-03-23, distributed nationwide. Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syph
| Recall number | Z-0806-2022 |
|---|---|
| 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 | 2022-02-08 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, DE, ES, FR, IT, SA |
| Quantity | 9,426 packages |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 03610520653012 |
| Lot numbers | 301336 |
| Model numbers | 12000650 |
Product
BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
Reason for recall
Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
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-0806-2022. 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.