BEUDAMED
    FDA Recall 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 · Initiated October 28, 2016

    Recall

    Recall Number
    Z-1053-2017
    Event Number
    76050
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 28, 2016
    Posted
    January 19, 2017
    Terminated
    July 27, 2017
    Address
    8 Calthorpe Road, Birmingham 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.

    Action

    Binding Site sent an Important Notice dated October 28, 2016, to all affected customers. . Binding Site requests the following: - Immediately quarantine and dispose of any LK018.S lot 400012 / LK018.10S lot 400257 kits held in your organisation; - Remove any affected lots from the SPAPLUS instrument; - Contact Binding Site representative to request replacement kits; - Return completed E-back form to your local Binding Site representative. For questions regarding this recall call 858-453-9177.

    Distribution

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

    Quantity

    3,088