BEUDAMED
    FDA Recall Terminated

    Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-1498-04 · Initiated August 27, 2004

    Recall

    Recall Number
    Z-1498-04
    Event Number
    29922
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LOM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 27, 2004
    Posted
    September 30, 2004
    Terminated
    July 29, 2005
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064

    Reason

    There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

    Action

    Abbott affiliates in Canada, Germany, Australia, New Zealand, England and Japan were e-mailed copies of the recall letter on 8/27/04 for translation where needed and dissemination to their accounts receiving the suspect lots. The end users were advised of the potential for significant differences in quantitative results for certain specimens and were instructed to discontinue use and destroy any of the affected lots remaining.

    Distribution

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

    Quantity

    6,691 kits