BEUDAMED
    FDA Recall Terminated

    Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-0209-04 · Initiated November 5, 2003

    Recall

    Recall Number
    Z-0209-04
    Event Number
    27667
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 5, 2003
    Posted
    December 11, 2003
    Terminated
    July 20, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    Architect Anti-HBs Reagent Kit; list 7C18-25, 100 tests and list 7C18-20, 4 x 100 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Reason

    Aspiration errors in the conjugate component due to microbial contamination of the conjugate.

    Action

    Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 11/5/03 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the aspiration errors in the conjugate component and were instructed to discontinue use and destroy any of the affected lots remaining.

    Distribution

    Canada, Japan, Australia, New Zealand, Germany and England

    Quantity

    2,244 kits