Defendants: Sovo Tec Diagnostics, Inc.; Amhad Shirzadi; and Deborah Colby

Type:  Deceptive Health Product Claims

The Commission brought suit against the apparent distributor of faulty HIV test kits sold by Cyberlinx, a defendant in an earlier FTC suit. According to an FDA warning letter, Cyberlinx's test were labeled, "HIV ½ STAT-PAK Ultra Fast manufactured for Sovo Tec Diagnostics, Inc." The FTC charged Sovo Tec Diagnostics, Inc. ("Sovo Tec"), its President, Amhad Shirzadi, and Sovo Tec's General Manager, Deborah Colby, with distributing rapid HIV tests under the names, "HIV ½ STAT-PAK Ultra Fast" and "HIV ½ Whole Blood" and deceptively claiming that these tests accurately detected HIV infection in human blood. According to the FTC, in some instances defendants' HIV tests did not accurately detect the presence of HIV antibodies.

The FTC obtained a stipulated final order from the defendants that prohibits them from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. FDA. The order also requires the defendants to (1) inform all past purchasers of the FTC settlement; (2) notify the Commission of any complaints or refund requests in the future; and (3) permit the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.

In approving this settlement, Commissioners Swindle and Leary issued separate concurring statements, noting with concern that Sovo Tec’s rapid HIV tests could be exported even though they were not approved for sale in the U.S. Both called for closer scrutiny of this problem by Congress.