BEUDAMED
    FDA Enforcement Class III Terminated

    ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

    Recall: Z-0536-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0536-2016
    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 CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

    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

    141779 142656 142963 143874 144562 151996

    Distribution

    Nationwide Distribution.

    Quantity

    492 kits