FDA warns about imported test kits.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 result in false results that could lead 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 THC tetrahydrocannabinol. THC n. Tetrahydrocannabinol; a compound that is obtained from cannabis or is made synthetically; it is the primary intoxicant in marijuana and hashish. ) Test, One Step Cassette Style Amphetamine Test. Rapid Dengue Fever Test, and One Step Midstream Style HCG HCG, hCG human chorionic gonadotropin. HCG abbr. human chorionic gonadotropin Human chorionic gonadotropin (hCG) Urine (Home) Pregnancy Test. The tests, sold through Web sites such as www.htkit.com and www.hstkits.com, have been distributed nationwide. The name of the kit appears on the instructions, but the envelope, instructions, and packaging may not accurately identify the manufacturer, packer, or distributor. No home-use test kits intended for diagnosing HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , syphilis, and dengue fever are approved for sale in the United States. |
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