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Bio-Rad Laboratories, Inc. recalls BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Recalled April 19, 2023 · FDA recall Z-1377-2023 · Bio-Rad Laboratories
Hazard
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. · FDA Class II
Units
1544 units
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
Description
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.
Product
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →