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Vaccines, Blood & Biologics

Unapproved Home-Use Diagnostic Kits Marketed by Globus Media-Medwatch

Home-Use Diagnostic Kits Marketed by Globus Media
Audience: Consumers and healthcare professionals
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.

 

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(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Silver Spring, MD 20993-0002

Page Last Updated: 06/25/2013
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