BEUDAMED
    FDA Enforcement Class II Terminated

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    Recall: Z-1050-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1050-2017
    Event ID
    76049
    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
    November 28, 2012
    Classification Date
    January 19, 2017
    Termination Date
    March 3, 2017
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    Reason

    Calibration curve activity has increased over time in the kit lots listed.

    Code Info

    Lot #323278, 327963

    Distribution

    U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

    Quantity

    1,002