BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.
- Product
- BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
- Category
- Medical Device
- Distribution
- Distributed nationwide