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 about when they discovered the defect, the extent of the problem and the risks associated with it, prosecutors said.
Attorneys for Winslow and Daoust did not immediately respond to requests for comment. Attorney information for Maleknia was not immediately available. The company said all devices the malfunction affected have been cleared by the FDA “and will remain available for clinical use.”
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