BEUDAMED
    FDA Enforcement Class III Terminated

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    Recall: Z-0506-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0506-2016
    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

    iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016

    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

    141971 142195 142397 142674 142997 144209 144463 150018 150883 151525 151526 152180 152741 153045 153150 153151 153211 153376 153650

    Distribution

    Nationwide Distribution.

    Quantity

    8,290 units