BEUDAMED
    FDA Enforcement Class II Ongoing

    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    Recall: Z-1016-2019 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1016-2019
    Event ID
    81783
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 27, 2019
    Initiation Date
    December 3, 2018
    Classification Date
    March 15, 2019
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    Description

    Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

    Reason

    The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

    Code Info

    498FR

    Distribution

    US Distribution to states to: CA, ME. MI, and WV.

    Quantity

    85 kits