BEUDAMED
    FDA Enforcement Class II Ongoing

    Calibration Serum Level 3 CAL2351

    Recall: Z-0752-2024 · Reported January 24, 2024

    Enforcement

    Recall Number
    Z-0752-2024
    Event ID
    93612
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 24, 2024
    Initiation Date
    November 20, 2023
    Classification Date
    January 18, 2024
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Calibration Serum Level 3 CAL2351

    Reason

    CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

    Code Info

    GTIN: 05055273200966 Lot Numbers: 1214UE, 1249UE, 1260UE, 1262UE, 1268UE, 1297UE, 1298UE, 1315UE

    Distribution

    US Nationwide and Puerto Rico.

    Quantity

    269 kits