BEUDAMED
    FDA Enforcement Class III Terminated

    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

    Recall: Z-3084-2017 · Reported September 6, 2017

    Enforcement

    Recall Number
    Z-3084-2017
    Event ID
    77702
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 6, 2017
    Initiation Date
    June 26, 2017
    Classification Date
    August 29, 2017
    Termination Date
    August 6, 2019
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    Description

    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine

    Reason

    The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.

    Code Info

    P/N IS10-DX; Lot No. U0731

    Distribution

    Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX

    Quantity

    263Kits