Bogus HIV tests
This article was originally published in The Gray Sheet
Executive Summary
Federal Trade Commission settles charges against Medford, New York-based Chembio Diagnostic Systems and San Diego-based Alfa Scientific Designs alleging the firms made false claims about the accuracy of unapproved rapid HIV antibody tests. The settlement bars the firms from making or assisting others in making false or misleading representations concerning the accuracy of any unapproved HIV test or other unapproved device. Over the past two years FTC has settled similar charges against distributors of both the Chembio and Alfa tests; however, the latest action is the first brought against manufacturers of such tests