BEUDAMED
    FDA Enforcement Class II Terminated

    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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-0301-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0301-2016
    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

    11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA 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

    142898 151145 142899

    Distribution

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

    Quantity

    150 units