BEUDAMED
    FDA Recall Terminated

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

    Recall: Z-2165-2017 · Initiated July 8, 2011

    Recall

    Recall Number
    Z-2165-2017
    Event Number
    77048
    Firm
    Medtest Holdings, Inc.
    FEI Number
    1827821
    Product Code
    CFJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 8, 2011
    Posted
    May 26, 2017
    Terminated
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261

    Description

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

    Reason

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.

    Action

    Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.

    Distribution

    Nationwide

    Quantity

    716.146L total