Feb. 9, 2005 -- The U.S. Food and Drug Administration (FDA) has warned consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media of Montreal, Canada, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. The tests were brought to the attention of the FDA in two consumer complaints.
The illegal products include the rapid HIV, dengue fever, and syphilis test kits; the one-step cassette-style tests for cocaine, marijuana, and amphetamines; a one-step midstream-style HCG urine test; and a pregnancy test.
The FDA notes that there are no home medical tests for HIV, syphilis, and dengue fever approved for sale in the U.S.
The Globus Media tests have not been evaluated for efficacy or approved by the FDA, and their use may produce false results. To date, no false positive results have been reported. The FDA warns that false negative results could lead to significant adverse health consequences due to lack of appropriate treatment and further communication of disease.
The tests were sold through websites (including www.htkit.com and www.hstkits.com, which this author has found to be disabled), and distributed throughout the U.S. via overnight delivery service. The kits included instructions with the test name, and were usually packaged in a paper envelope.
According to the FDA, the manufacturer, packer, and distributor may not be accurately identified on the envelope, instructions, and packaging.
The FDA advises consumers who have purchased these kits to refrain from using them, and to confirm results of prior use with valid testing methods.
The FDA has also issued an import alert to advise FDA field personnel and Customs officials of possible illegal importation of these devices into the U.S., and to provide guidance for their detention and refusal of admission.
According to a Canadian Broadcasting Corporation (CBC) news article posted yesterday, Health Canada is investigating whether Globus Media is importing the kits and/or selling them illegally in Canada and the U.S.
Adverse events related to use of Globus Media diagnostic tests should be reported to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Reviewed by Gary D. Vogin, MD
Medscape Medical News © 2005 Medscape
Cite this: Yael Waknine. Globus Media Home Medical Tests Illegal, Untested, and May Be Inaccurate, FDA Warns - Medscape - Feb 09, 2005.