BEUDAMED
    FDA Recall Terminated

    TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

    Recall: Z-1229-04 · Initiated May 28, 2004

    Recall

    Recall Number
    Z-1229-04
    Event Number
    29289
    Firm
    Abbott Health Products, Inc.
    FEI Number
    2623532
    Product Code
    DJG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 28, 2004
    Posted
    July 28, 2004
    Terminated
    September 10, 2004
    Address
    Hwy 2 Km 58.0, Barceloneta, PR, 00617

    Description

    TDx/TDxFLx Opiates Reagent, Product list number: 9673-60

    Reason

    Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.

    Action

    A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.

    Distribution

    Distribution was to hospitals/laboratories

    Quantity

    941 kits