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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Bio-Rad Laboratories, Inc.: 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

Agency Publication Date: March 16, 2022
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Affected Products

Product: BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack

Catalog Number: 12000650 UDI GTIN Code: 03610520653012 Lot Numbers: 301336

Lot Numbers:
03610520653012
Numbers
Product: BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL

Catalog Number: 12000651 UDI GTIN Code: 03610520652770 Lot Numbers: 53262

Lot Numbers:
03610520652770
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89684
Status: Active
Manufacturer: Bio-Rad Laboratories, Inc.
Manufactured In: United States
Units Affected: 2 products (9,426 packs (U.S.); 724 Calibrator sets (U.S.))

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.