105.  FTC v. Cyberlinx, Civ.Act.#CV-S-99-1564-PMP-LRL (D. Nev. November 1999)

Defendants: Cyberlinx and Jeffrey Stein

Type:  Defective HIV Home Test Kits

Defendants marketed HIV home test kits on the Internet and claimed that the tests accurately detected HIV infection in humans. However, the FDA tested the kits sold by Cyberlinx using blood serum samples known to contain antibodies to HIV (HIV-positive) and found that the test kits failed to consistently detect the presence of antibodies to HIV. On July 8, 1999, the FDA notified Cyberlinx's customers about the inaccurate test kit results. According to the FDA notification letter, the test kits were labeled "HIV ½ STAT-PAK Ultra Fast."

The Commission alleged that defendants falsely represented the accuracy of their HIV test kits. Cyberlinx and Stein entered a stipulated final order which imposed a lifetime ban on them from marketing or selling any HIV home test kit. The order also required them to post a $500,000 bond, or a $1,000,000 if acting jointly, if they ever wished to market or sell any other medical device.  Cyberlinx and Stein were required to pay the FTC money they received from the sale of their HIV test kits and were barred from transferring, disclosing, or selling information regarding any person who paid any money to either of them in connection with the purchase of any HIV home test kit.