BEUDAMED
    FDA Recall Terminated

    IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064

    Recall: Z-1129-03 · Initiated July 22, 2003

    Recall

    Recall Number
    Z-1129-03
    Event Number
    26868
    Firm
    Abbott Laboratories HPD/ADD/GPRD
    FEI Number
    1415939
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2003
    Posted
    August 13, 2003
    Terminated
    September 16, 2003
    Address
    100/200 Abbott Park Road, Abbott Park, IL, 60064

    Description

    IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064

    Reason

    The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.

    Action

    Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.

    Distribution

    California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras

    Quantity

    423 kits