BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1377-2023 · Initiated February 21, 2023

    Recall

    Recall Number
    Z-1377-2023
    Event Number
    91854
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3022521
    Product Code
    NHX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 21, 2023
    Posted
    April 12, 2023
    Address
    6565 185th Ave Ne, Redmond, WA, 98052-5039

    Description

    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.

    Action

    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.

    Distribution

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

    Quantity

    1544 units