BEUDAMED
    FDA Enforcement Class III Terminated

    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

    Recall: Z-2649-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2649-2017
    Event ID
    77453
    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
    November 22, 2010
    Classification Date
    June 29, 2017
    Termination Date
    July 24, 2017
    Address
    5449 Research Dr, N/A, Canton, MI, 48188-2261, United States

    Description

    The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

    Reason

    Incorrect control range in product labeling

    Code Info

    Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03

    Distribution

    FL, AR, NICARAGUA, KOREA

    Quantity

    5 kits