BEUDAMED
    FDA Recall Terminated

    AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    Recall: Z-0846-04 · Initiated March 22, 2004

    Recall

    Recall Number
    Z-0846-04
    Event Number
    28729
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2004
    Posted
    July 20, 2004
    Terminated
    April 13, 2007
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75015-2020

    Description

    AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas

    Reason

    Change of level 3 error log messages to level 1 to prevent suspect assay results.

    Action

    The recall was initiated by letter on March 22, 2004. The letter instructed customers regarding steps to change the error levels on each AEROSET system.

    Distribution

    Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Australia

    Quantity

    656