FDA Warns Consumers Not to Use Globus Media's Diagnostic Kits

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. and, as a result, could result in false results. The FDA learned of the problem from two consumer complaints.

The 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. The tests were sold through websites and distributed throughout the U.S., usually by overnight delivery services.

To view the illegal kits, go to http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01340.html (http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01340.html).