Former Execs of Medical Company Charged with Concealing Faulty Lead-Test Device

Three former top executives of Magellan Diagnostics, a Massachusetts-based medical device company, have been charged with conspiracy to commit wire fraud, wire fraud, conspiracy to defraud an agency of the United States, and introduction of misbranded medical devices into interstate commerce with intent to defraud and mislead. The executives allegedly concealed a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients. The malfunction affected Magellan's LeadCare devices, which detect lead levels and lead poisoning in the blood of children and adults. The FDA issued a Class I recall in February 2023 for several of Magellan's blood lead testing products because the performance of the test might provide falsely low results and could lead to health risks in young children and pregnant women.