Recall Z-1378-2023

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 positivesBio-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 positivesBio-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.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.

FDA-determined cause: Under Investigation by firm

Action taken

On February 21, 2023, Bio-Rad Laboratories issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recall, Bio-Rad asked consignees to take the following actions: 1. We are requesting that customers discontinue the use of and dispose of according to local waste management procedures any unused BioPlex 2200 Anti-CCP Reagent Pack (Catalog No. 665-3250, UDI GTIN 00847865000857) Lot No. 301481 and BioPlex 2200 Anti-CCPCalibrator Set (Catalog No. 663-3200, UDI GTIN 00847865000819) Lot No. 53727. 2. If you have distributed or transferred this product to any other Bio-Rad customers, or to any other laboratories from your site, please notify those customers of this field action. 3. Please complete the attached Customer Response Form and return it to your local Bio-Rad Technical Support so they can assist you with obtaining replacement reagent packs and calibrator sets Bio-Rad is working to provide a new lot of BioPlex 2200 Anti-CCP Reagent Pack and matching calibrator sets as soon as possible. Please provide the number of replacement units required in the attached customer response form.