BEUDAMED
    FDA Recall 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 · Initiated April 5, 2013

    Recall

    Recall Number
    Z-1329-2013
    Event Number
    64800
    Firm
    Medtox Diagnostics Inc
    FEI Number
    1050155
    Product Code
    DIO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 5, 2013
    Posted
    May 16, 2013
    Terminated
    September 12, 2013
    Address
    1238 Anthony Rd, Burlington, NC, 27215-8936

    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.

    Action

    MEDTOX issued "URGENT MEDICAL DEVICE RECALL" letters dated April 3, 2013 to consignees informing them of the recall. The letter requested that they examine their inventory and immediately discontinue all use and distribution of the affected lots. The letter also requested that they immediately inform clinicians of the recall at the testing sites that have utilized the recall product. The letter also included a Customer Verification Form which was to be returned.

    Distribution

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

    Quantity

    221,625