BEUDAMED
    FDA Recall Terminated

    Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

    Recall: Z-1446-2012 · Initiated March 12, 2010

    Recall

    Recall Number
    Z-1446-2012
    Event Number
    61637
    Firm
    Alere San Diego dba Biosite Innovacon Hemosense Inc
    FEI Number
    1000125596
    Product Code
    DJR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 12, 2010
    Posted
    April 20, 2012
    Terminated
    April 23, 2012
    Address
    9975 Summers Ridge Rd, San Diego, CA, 92121-2997

    Description

    Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

    Reason

    The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.

    Action

    Biosite sent a "PRODUCT ADVISORY NOTICE" letter dated March 12, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter states that customers may continue to use the product. Customers were instructed to complete and fax an enclosed verification form to Technical Services at 1-858-695-7100. Customers with any questions about the information contained in the notification were instructed to contact Biosite Inc. at (888) 246-7483.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada and European Union.

    Quantity

    1,258,002 kits