BEUDAMED
    FDA Recall Terminated

    Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

    Recall: Z-0607-2009 · Initiated October 10, 2008

    Recall

    Recall Number
    Z-0607-2009
    Event Number
    50162
    Firm
    Diamedix Corporation
    FEI Number
    1044713
    Product Code
    LJB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 10, 2008
    Posted
    January 7, 2009
    Terminated
    May 12, 2010
    Address
    2140 N. Miami Avenue, Miami, FL, 33127

    Description

    Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

    Reason

    Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with the MAGO Plus/Aptus sensing of and picking up of samples. As a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.

    Action

    Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.

    Distribution

    Worldwide Distribution --- including USA and country of England.

    Quantity

    974Test Kits