BEUDAMED
    FDA Recall Terminated

    The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

    Recall: Z-0274-04 · Initiated October 29, 2003

    Recall

    Recall Number
    Z-0274-04
    Event Number
    27730
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2003
    Posted
    December 25, 2003
    Terminated
    November 13, 2007
    Address
    1921 Hurd Drive PO Box 152020, Irving, TX, 75038

    Description

    The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

    Reason

    Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.

    Action

    All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.

    Distribution

    Worldwide

    Quantity

    17,850