BEUDAMED
    FDA Enforcement Class II Terminated

    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.

    Recall: Z-1508-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1508-2014
    Event ID
    67818
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Branan Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    March 26, 2014
    Classification Date
    April 24, 2014
    Termination Date
    July 23, 2014
    Address
    140 Technology Dr Ste 400, N/A, Irvine, CA, 92618-2426, United States

    Description

    ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.

    Reason

    May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

    Code Info

    Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079

    Distribution

    Worldwide Distribution: US (nationwide) and country of Canada.

    Quantity

    9,800 units