FDA recall Z-1377-2023

Bio-Rad Laboratories, Inc. · Class II · device

Product

BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.

Key facts

Status: Ongoing
Initiation date: 2023-02-21
Report date: 2023-04-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1377-2023