Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total Recalled by Bio-Rad Laboratories, Inc. Due to Due to two issues: 1) Customer complaints associated...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Rad Laboratories, Inc. directly.
Affected Products
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
Quantity: 11,610 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report