BEUDAMED
    FDA Enforcement Class II Ongoing

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD

    Recall: Z-1378-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1378-2023
    Event ID
    91854
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 19, 2023
    Initiation Date
    February 21, 2023
    Classification Date
    April 12, 2023
    Address
    6565 185th Ave Ne, N/A, Redmond, WA, 98052-5039, United States

    Description

    BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, 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 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.

    Code Info

    Lot # 53727; UDI GTIN: 00847865000819

    Distribution

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

    Quantity

    225 units