BEUDAMED
    FDA Recall Open, Classified

    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

    Recall: Z-1286-2023 · Initiated February 1, 2023

    Recall

    Recall Number
    Z-1286-2023
    Event Number
    91745
    Firm
    Randox Laboratories
    FEI Number
    3003059701
    Product Code
    DCK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 1, 2023
    Posted
    September 30, 2024
    Address
    515 Industrial Blvd, Kearneysville, WV, 25430-2778

    Description

    CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826

    Reason

    The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

    Action

    Randox UK (manufacturer) extended Urgent Medical Device Removal letter to the US distributor via email on 2/1/23. The distributor contacted the customer via email on 2/6/23. Letter states reason for recall, health risk and action to take: " Discontinue use of and discard any of the above immediately. Provide Randox with photographic evidence of the destruction of the kits. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. If you have any questions or concerns, please contact Randox Technical Services.

    Distribution

    PA, OH, WV

    Quantity

    2 kits