The Food and Drug Administration warned consumers Friday not to use two at-home medical tests for the AIDS virus and hepatitis, saying they were fraudulently sold by a California company.
Neither product - the “Lei-Home Access HIV Test” and the “In-home Hepatitis A Test Kit” - has been shown to work, the FDA 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 samples 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 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.
Attempts to locate Jin-Greene were unsuccessful. The company had no listed phone number, and the toll-free number advertised on the Internet was out of service.
The FDA has approved one athome test kit for the AIDS virus, Home Access Health Corp.’s Home Access HIV-1 Test System. Users prick a finger, smudge a blood spot on a special card identified only by a numerical code, and mail the card to a laboratory. The user then calls a hot line, provides the code and learns the test results from a trained counselor.