FDA MedWatch: Consumer Alert to not use unapproved Home-Use Diagn ostic Kits Marketed

  1. MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    The FDA warned consumers not to use unapproved home-use diagnostic test kits
    that have been marketed nationwide via the Internet by Globus Media,
    Montreal, Canada. No home-use test kits intended for diagnosing HIV,
    syphilis and dengue fever are approved for sale in the U.S. The use of these
    products could result in false results (though there is no confirmed
    evidence of false positives) that could lead to significant adverse health
    consequences. The tests were sold through web sites and distributed
    throughout the U.S., usually by overnight delivery services. FDA has not
    approved or evaluated the performance of any of Globus Media's products. As
    a result, consumers cannot know with any degree of certainty that test
    results are correct. See the FDA Talk Paper for a complete list of all test
    kits affected by this notice.

    Read the complete MedWatch 2005 safety summary, including links to the FDA
    Talk Paper, at
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