BEUDAMED
    FDA Enforcement Class II Terminated

    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

    Recall: Z-1053-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1053-2017
    Event ID
    76050
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Binding Site Group, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    October 28, 2016
    Classification Date
    January 19, 2017
    Termination Date
    July 27, 2017
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

    Reason

    A change in the calibration curve causing an increase in false prozone flags.

    Code Info

    Lot #400012, 400257

    Distribution

    Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.

    Quantity

    3,088