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Ex-Magellan Diagnostics execs charged with concealing lead-test defect


Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

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 on Wednesday.

Amy Winslow, Hossein Maleknia and Reba Daoust misled Magellan customers and the Food and Drug Administration (FDA) about when they discovered the defect, the extent of the problem and the risks associated with it, prosecutors said.

Winslow, the company’s former CEO, Maleknia, the former chief operating officer, and 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.

Attorneys for Winslow and Daoust did not immediately respond to requests for comment. Attorney information for Maleknia was not immediately available.

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 company said all devices the malfunction affected have been cleared by the FDA “and will remain available for clinical use.”

Magellan Diagnostics ultimately recalled all three devices in 2021 and resumed distribution last year, according to the FDA.

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.

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.

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