BEUDAMED
    FDA Enforcement Class II 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 · Reported June 7, 2017

    Enforcement

    Recall Number
    Z-2165-2017
    Event ID
    77048
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 7, 2017
    Initiation Date
    July 8, 2011
    Classification Date
    May 26, 2017
    Termination Date
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    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.

    Code Info

    L7572 all configurations

    Distribution

    Nationwide

    Quantity

    716.146L total