BEUDAMED
    FDA Enforcement Class III Terminated

    Alere iScreen Dx Urine Drug Screen Card

    Recall: Z-1542-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1542-2018
    Event ID
    79549
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    December 15, 2017
    Classification Date
    April 28, 2018
    Termination Date
    February 11, 2019
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    Description

    Alere iScreen Dx Urine Drug Screen Card

    Reason

    The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.

    Code Info

    Part No. X11-IS10-Dx, Lot No. 173351, 173686, 174055, 176002.

    Distribution

    Distributed domestically to AZ, FL, IL, ND, NV, PA, TN, TX, VA.

    Quantity

    828 kits (20,700 devices)