BEUDAMED
    FDA Recall 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 · Initiated June 26, 2017

    Recall

    Recall Number
    Z-3084-2017
    Event Number
    77702
    Firm
    Ameditech Inc
    FEI Number
    3003789989
    Product Code
    LFH
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 26, 2017
    Terminated
    August 6, 2019
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910

    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.

    Action

    Ameditech, Inc. sent an Medical Device Labeling Correction letter to all affected consignees. Remaining product at the firm was quarantined and will be scrapped. Consignees will be notified of the labeling error with a correction notification. The kit label has been corrected and is available for future product. The firm plans to conduct effectiveness checks based upon receipt of the Label Correction notification by consignees. Firm indicates that no customer action is required, so no formal reply from distributors is necessary. Customers who have not had confirmed receipt of correction notification will be telephoned. For questions regarding this recall call 858-805-3607.

    Distribution

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

    Quantity

    263Kits