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

[Brian, ASN, RN]

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

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#HomeUse