BEUDAMED
    FDA Recall Terminated

    IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-0293-04 · Initiated November 23, 2003

    Recall

    Recall Number
    Z-0293-04
    Event Number
    27835
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    CGN--
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 23, 2003
    Posted
    January 6, 2004
    Terminated
    July 22, 2004
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    IMx Folate Reagent Pack, list 2220-88 (100 tests - reagents packaged with Ion Capture Reaction Cells) and list 2220-20 (100 tests - reagents alone); Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples, which would result in falsely elevated folate values, when performing IMx Folate testing.

    Action

    Abbott notified their international affiliates via e-mail on 11/23/03. Important Product Information letters dated 11/24/03 will be sent to the end users by the affiliates, informing them of the possible methotrexate carryover to subsequent samples and falsely elevated folate values.

    Distribution

    There was no U.S. distribution. The product was internationally distributed through Abbott subsidiaries in Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England and Australia.

    Quantity

    3,475 packs