BEUDAMED
    FDA Recall Terminated

    Alere iScreen Dx Urine Drug Screen Card

    Recall: Z-1542-2018 · Initiated December 15, 2017

    Recall

    Recall Number
    Z-1542-2018
    Event Number
    79549
    Firm
    Ameditech Inc
    FEI Number
    3003789989
    Product Code
    LFH
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 15, 2017
    Terminated
    February 11, 2019
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910

    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.

    Action

    Customers were notified on about 12/15/2017. Instructions included to become aware of the recall so as to relay the information to customers with questions.

    Distribution

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

    Quantity

    828 kits (20,700 devices)