Magellan Diagnostics Sentenced For Concealing Malfunction In Lead Testing Devices
Company failed to notify FDA about serious malfunction in lead testing devices that resulted in inaccurately low blood level results in children and adults
BOSTON –Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., was sentenced yesterday in federal court in Boston for criminal charges related to the concealment of a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients.
Action Details
- Date:October 10, 2024
- Agency:U.S. Attorney's Office, District of Massachusetts
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Enforcement Types:
- Criminal and Civil Actions