BEUDAMED
    FDA Enforcement Class III Terminated

    ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

    Recall: Z-0526-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0526-2016
    Event ID
    72651
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    November 16, 2015
    Classification Date
    December 24, 2015
    Termination Date
    November 9, 2016
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    Description

    ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU

    Reason

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

    Code Info

    G140258 G140313 G140314 G140368 G140384 G140389 G140399 G140426 G150185 G150199 G150246 G150307

    Distribution

    Nationwide Distribution.

    Quantity

    7,805 kits