The Food and Drug Administration is warning consumers about possible false results from several unapproved home-use diagnostic test kits marketed in the United States via the Internet by Globus Media of Montreal.
The test kits are not approved for sale in the United States. There is concern that the use of these products could lead to false results that could contribute to significant adverse health consequences, but there are no confirmed instances of false results, according to the FDA.
The kits are labeled as Rapid HIV Test Kit, Rapid Syphilis Test Kit, One Step Cassette Style Cocaine Test, One Step Cassette Style Marijuana (THC) Test, One Step Cassette Style Amphetamine Test, Rapid Dengue Fever Test, and One Step Midstream Style HCG Urine (Home) Pregnancy Test.
The tests, sold through Web sites such as www.htkit.com
No home-use test kits intended for diagnosing HIV, syphilis, and dengue fever have been approved for sale in the United States.