BEUDAMED
    FDA Recall Terminated

    LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082

    Recall: Z-1240-2008 · Initiated February 1, 2008

    Recall

    Recall Number
    Z-1240-2008
    Event Number
    46832
    Firm
    Diasorin Inc.
    FEI Number
    2182595
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 1, 2008
    Posted
    May 7, 2008
    Terminated
    October 31, 2008
    Address
    1951 Northwestern Ave S P.O Box 285, Stillwater, MN, 55082-0285

    Description

    LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082

    Reason

    Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.

    Action

    Consignees were notified by a Diasorn Customer Notification Letter sent by email on 2/1/08. The letter instructs users to stop using the affected kits, destroy any kits remaining in inventory and to return a response form in order to receive replacement product. For additional information contact 1-800-328-1482.

    Distribution

    Worldwide Distribution including USA states of AR, CA, GA, IA, IL, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OR, PA, TN, UT and WA and country of Austria.

    Quantity

    2,267 kits