BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    Recall: Z-2650-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2650-2017
    Event ID
    77445
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 5, 2017
    Initiation Date
    October 19, 2011
    Classification Date
    June 29, 2017
    Termination Date
    July 24, 2017
    Address
    5449 Research Dr, N/A, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

    Reason

    Linear performance information in product insert does not match that listed in the approved premarket notification

    Code Info

    Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.

    Distribution

    Nationwide Distribution

    Quantity

    319.922 L