FDA Device recall Z-0235-2022
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow im…
- FDA Device
- Class II
- ongoing
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow im… by Bio Rad Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0235-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-17 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number: 12000650 UDI Code: 03610520653012 Lot Number: 301210 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0235-2022%22
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