Three former executives of medical device company Magellan Diagnostics concealed a malfunction in the company’s lead-testing devices that caused tests to underestimate the level of lead in people’s blood, U.S. prosecutors in Boston said in announcing criminal charges.
Amy Winslow, the company’s former CEO, Hossein Maleknia, the former chief operating officer, and Reba Daoust, the former director of quality assurance and regulatory affairs, were indicted in U.S. district court in Massachusetts on charges including conspiracy to commit wire fraud and conspiracy to defraud a U.S. agency.
A spokesperson for Meridian BioScience Inc, which purchased Magellan in 2016, said the company has cooperated with the federal investigation that led to the indictment and it expects to pay a fine as part of a corporate resolution with the U.S. Justice Department. That agreement has not been finalized.
The malfunction affected three of Magellan’s lead-testing devices, including one that accounted for more than half of all blood lead tests conducted in the U.S. between 2013 and 2017, according to prosecutors.
Magellan Diagnostics ultimately recalled all three devices in 2021 and resumed distribution last year. The company said all devices the malfunction affected have been cleared by the FDA “and will remain available for clinical use.”
Rachael Rollins, the U.S. attorney in Massachusetts, said the executives “endangered the health and lives of incredibly vulnerable victims,” including the poor and young children, who are at most at risk of lead exposure.
Attorneys for Winslow and Daoust did not immediately respond to requests for comment. Attorney information from Maleknia was not immediately available.