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Company: Magellan Diagnostics, Inc.
Penalty: $42,000,000
Year: 2024
Date: May 21, 2024
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Mega-Scandal:
Medical Equipment Hazards
Violation Description: Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., agreed to resolve criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for potentially tens of thousands of children and other patients. As part of the criminal resolution, Magellan agreed tol plead guilty to violations of the federal Food, Drug and Cosmetics Act and pay a $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims. The resolution also includes a deferred prosecution agreement to resolve felony conspiracy fraud charges against the company.
Level of Government: federal
Action Type: agency action
Agency: U.S. Attorney-District of Massachusetts
Civil or Criminal Case: criminal
Prosecution Agreement: deferred prosecution agreement and plea
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the
Update Log.