BEUDAMED
    FDA Recall Terminated

    AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)

    Recall: Z-1047-03 · Initiated June 12, 2003

    Recall

    Recall Number
    Z-1047-03
    Event Number
    26530
    Firm
    Abbott Laboratories HPD/ADD
    FEI Number
    1415939
    Product Code
    LOK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 12, 2003
    Posted
    July 24, 2003
    Terminated
    November 21, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21(French label); and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0), 3D50-03 (Version 3.0), and 3D50-04 (Version 4.0)

    Reason

    AFP results obtained when using the 1:101 automated dilution protocol showed an overestimation of AFP of up to 30.5%

    Action

    All AxSYM AFP customers were informed not to use the 1:101 automated dilution protocol via Device Correction letter dated 6/12/03. If necessary, manually dilute samples per the AxSYM AFP package insert.

    Distribution

    Nationwide and internationally to Australia, Canada, Costa Rica, Ecuador, Japan, Panama, San Salvador, Thailand, Barbados, Chili, Curacao, Honduras, Korea, Peru, Singapore, United Kingdom, Brazil, Columbia, Dominican Republic, Hong Kong, Pakistan, St. Vincent, Uruguay

    Quantity

    23,000 kits