Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioPlex 2200 Recalled by Bio-Rad Laboratories, Inc. Due to Bio-Rad received four customer complaints from 11/30/2022 to...
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
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Quantity: 1544 units
Why Was This Recalled?
Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.
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