BEUDAMED
    FDA Recall Terminated

    XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-1474-04 · Initiated September 1, 2004

    Recall

    Recall Number
    Z-1474-04
    Event Number
    29957
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2004
    Posted
    September 18, 2004
    Terminated
    November 30, 2004
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.

    Action

    Abbott sent Device Correction letters dated 9/1/04 to all customers receiving the TDx/TDxFLx Benzodiazepines assay, list 9674, informing them of the shift in control values and patient results when used with the XSYSTEMS Dilution Buffer, list 9519-02. The letter gave examples of the effects observed in the benzodiazepines assay performance, and listed the following actions to be taken until Abbott completes their investigation: * During the use of a single lot of buffer, recalibrate the TDx/TDxFLx Benzodiazepines assay every 14 days. * Perform a new calibration run on the TDx/TDxFLx Benzodiazepines assay when a new lot number of XSYSTEMS Dilution Buffer is used. * These actions are in addition to the package insert calibration and quality control requirements. * Follow your laboratory procedures for notification of the health care providers that you serve. Any questions were directed to Abbott''s Customer Service at 1-877-4ABBOTT.

    Distribution

    Nationwide and internationally to Argentina, Australia, Brazil, Chile, Colombia, Costa Rica, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Mexico, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand, the United Kingdom, Uruguay and Venezuela

    Quantity

    22,442 cartons