BEUDAMED
    FDA Enforcement Class III Terminated

    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

    Recall: Z-2121-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2121-2017
    Event ID
    77083
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtest Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 31, 2017
    Initiation Date
    May 15, 2014
    Classification Date
    May 20, 2017
    Termination Date
    June 2, 2017
    Address
    5449 Research Dr, Canton, MI, 48188-2261, United States

    Description

    Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.

    Reason

    The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

    Code Info

    Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).

    Distribution

    Nationwide

    Quantity

    132919 Vol vials