FDA ISSUES WARNING NOT TO USE TESTS.Byline: Associated Press The Food and Drug Administration warned consumers Friday not to use two at-home medical tests for the AIDS virus AIDS virus n. See HIV. and hepatitis, saying they were fraudulently sold by a California company. Neither product - the ``Lei-Home Access 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. Test'' and the ``In-home Hepatitis A Hepatitis A Definition Hepatitis A is an inflammation of the liver caused by a virus, the hepatitis A virus (HAV). It varies in severity, running an acute course, generally starting within two to six weeks after contact with the virus, and lasting no Test Kit'' - has been shown to work, the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. said. Anyone who already has used the products should consider being retested, the FDA said. In fact, the agency said it could not be sure that blood samples consumers mailed to the company were checked for the viruses. ``We have no information at this time that any units were actually tested,'' said FDA compliance officer Steve Masiello. ``Anyone who's used a kit from an unapproved un·ap·proved adj. Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. source has to question the results.'' The kits were sold by Lei-Home Access Care, a division of Jin-Greene Biotechnology Inc. of Sunnyvale, Calif. They were sold largely over the Internet, on a site that claims 100,000 HIV tests were sold in eight months. But the FDA said some pharmacies also sold them, and urged all pharmacists to remove the unapproved tests from store shelves immediately. |
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