BEUDAMED
    FDA Recall Terminated

    ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas

    Recall: Z-1133-03 · Initiated December 10, 2001

    Recall

    Recall Number
    Z-1133-03
    Event Number
    26639
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 10, 2001
    Posted
    August 13, 2003
    Terminated
    August 12, 2003
    Address
    1921 Hurd Drive PO Box 2020, Irving, TX, 75038

    Description

    ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas

    Reason

    Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

    Action

    Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.

    Distribution

    Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.

    Quantity

    787