BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1043-2017 · Initiated July 5, 2016

    Recall

    Recall Number
    Z-1043-2017
    Event Number
    76048
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DEH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 5, 2016
    Posted
    January 18, 2017
    Terminated
    July 3, 2017
    Address
    8 Calthorpe Road, Birmingham 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.

    Action

    On 07/05/16 notification letters were sent to customers. The Binding Site Group requests the following: - Immediately Quarantine & Dispose of any LK018.OPT lot 405566 kits within stock; - Remove any affected lots from the Optilite instrument; - Patients with Lambda Freelite results >114mg/L should be reviewed in consultation with clinicians, alongside other clinical findings and retested where applicable; - Notify local Binding Site representative to request replacement kits; - Return completed E-Back Form to local Binding Site Representative; The firm recommended that the notice be circulated to those within the organization who need to be aware.

    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