Recall Z-1377-2023— Bio-Rad Laboratories, Inc.
Class II · Ongoing
Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2023-02-21. It names 2 FDA 510(k) clearances: K112810, K093954. Product: BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD. 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..
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-21
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K112810 — MULTI-ANALYTE DETECTION SYSTEMS
- K093954 — BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.