Florida Company Fined for Selling Unlicensed HIV Saliva Test Kit
Hallendale Beach, Fla.-based SMLX Technologies, Inc., has been ordered to pay $347,500 in penalties for selling HIV saliva test kits that were never approved by the FDA, the AP/South Florida Sun-Sentinel reports. Federal prosecutors said Thursday that the company had "submitt[ed] false test data" on the kits to the FDA and foreign regulators. Most of the kits had been sold in Latin America under the name Simplex Rapid HIV Saliva Test (AP/South Florida Sun-Sentinel, 5/3). SMLX executives Henry Schur and Nicholas Levandoski earlier were sentenced to 15 months in prison for mail fraud and "making false statements to the FDA." Schur, Levandoski and their company were ordered to pay $197,500 in restitution, and the firm was fined $150,000 (AP/Miami Herald, 5/3).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.