Magellan Diagnostics admits to concealing device malfunction, pays $42m to resolve charges, and three executives arrested for deceiving FDA and customers.

Magellan Diagnostics, a Massachusetts-based medical device company, admitted to concealing a device malfunction that produced inaccurately low lead test results, agreeing to pay $42 million to resolve criminal charges. The company will plead guilty to violations of the federal Food, Drug, and Cosmetics Act, and a deferred prosecution agreement resolves felony conspiracy fraud charges. Three former executives were also arrested for allegedly deceiving customers and the FDA about the reliability of lead-testing devices.

May 21, 2024
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