Device product
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Z-1377-2023
Product summary
- Event
- Event 91854
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1544 units
- Official record key
device-enforcement:Z-1377-2023
Official wording
Reason: 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.
Code information: Lot # 301481; UDI GTIN: 00847865000857
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
Derived failure modes
-
Unknown
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.