BEUDAMED
    FDA Enforcement Class II 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 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0073-2015
    Event ID
    69333
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2014
    Initiation Date
    September 23, 2014
    Classification Date
    October 16, 2014
    Termination Date
    February 27, 2015
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    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.

    Code Info

    Lot No. 141001

    Distribution

    Distributed in AL.

    Quantity

    320 kits