BEUDAMED
    FDA Enforcement Class III Terminated

    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

    Recall: Z-2490-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2490-2019
    Event ID
    83373
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    July 12, 2019
    Classification Date
    September 7, 2019
    Termination Date
    June 17, 2020
    Address
    55 Diamond Road, Crumlin (North), N/A, Ireland

    Description

    This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.

    Reason

    Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

    Code Info

    Lot Numbers: 961UE onwards GTN: 05055273200966

    Distribution

    Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

    Quantity

    307 kits