BEUDAMED
    FDA Enforcement Class II Terminated

    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    Recall: Z-0316-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0316-2016
    Event ID
    72471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 25, 2015
    Initiation Date
    October 20, 2015
    Classification Date
    November 18, 2015
    Termination Date
    November 9, 2016
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    Description

    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    Reason

    Ameditech is recalling drug abuse tests because they have shown reduced reactivity.

    Code Info

    G140422-C G150059-C G150063-C G150132-C

    Distribution

    Worldwide Distribution - US (nationwide) and Internationally to Australia.

    Quantity

    2,240 units