BEUDAMED
    FDA Enforcement Class II Terminated

    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

    Recall: Z-1043-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1043-2017
    Event ID
    76048
    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
    July 5, 2016
    Classification Date
    January 18, 2017
    Termination Date
    July 3, 2017
    Address
    8 Calthorpe Road, Birmingham, N/A, United Kingdom

    Description

    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

    Reason

    Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.

    Code Info

    Lot #405566, 405567

    Distribution

    U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.

    Quantity

    809 kits