BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay — Class II medical device recall Z-2982-2020
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2020-09-30, distributed nationwide. The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
| Recall number | Z-2982-2020 |
|---|---|
| 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 | 2020-04-21 |
| Classified | 2020-09-18 |
| Reported by FDA | 2020-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, ES, FR, GB, IT, RO |
| Quantity | 12,000 kits |
| UPC / GTIN / UDI-DI | 03610520652770, 03610520653012 |
| Lot numbers | 301142, 52216 |
| Model numbers | 12000650, 12000651 |
Product
BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.
Reason for recall
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
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-2982-2020. 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.