BEUDAMED
    FDA Recall Terminated

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    Recall: Z-0073-2015 · Initiated September 23, 2014

    Recall

    Recall Number
    Z-0073-2015
    Event Number
    69333
    Firm
    Ameditech Inc
    FEI Number
    3003789989
    Product Code
    DKZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 23, 2014
    Posted
    October 16, 2014
    Terminated
    February 27, 2015
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910

    Description

    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.

    Reason

    Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.

    Action

    A customer notification letter dated 9/23/14 was sent to all customers who purchased the ArcPoint Labs Dip Drug Screen Dip Card. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the Verification Form. Customers with questions are instructed to contact Ameditech at (858) 805-8714 or email at [email protected].

    Distribution

    Distributed in AL.

    Quantity

    320 kits