BEUDAMED
    FDA Enforcement Class II Terminated

    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

    Recall: Z-1329-2013 · Reported May 22, 2013

    Enforcement

    Recall Number
    Z-1329-2013
    Event ID
    64800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtox Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2013
    Initiation Date
    April 5, 2013
    Classification Date
    May 16, 2013
    Termination Date
    September 12, 2013
    Address
    1238 Anthony Rd, Burlington, NC, 27215-8936, United States

    Description

    PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,

    Reason

    Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.

    Code Info

    Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part No. 604019 - Lot No. 6321, 6331, 6341, 6351; Part No. 604020 - Lot No. 6361, 6371; Part No. 604022 - Lot No. 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661, 6671, 6672, 6681; Part No. 604026 - Lot No. 6041, 6051; Part No. 604028 - Lot No. 6051, 6061, 6071, 6081, 6091,

    Distribution

    Worldwide distribution: USA (nationwide) and in the country of: Canada.

    Quantity

    221,625