BEUDAMED
    FDA Enforcement Class II Terminated

    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    Recall: Z-0660-2019 · Reported January 2, 2019

    Enforcement

    Recall Number
    Z-0660-2019
    Event ID
    81664
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2019
    Initiation Date
    November 19, 2018
    Classification Date
    December 21, 2018
    Termination Date
    April 23, 2020
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG and IgM assays that require sample predilution.

    Reason

    Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.

    Code Info

    05055273204049 Lot Number: 415879 Date of Expiry - 28 March 2019

    Distribution

    US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.

    Quantity

    250 kits (32 kits US / 218 kits OUS)