Magellan Diagnostics, Inc. has been ordered to pay a $21.8 million fine, $10.9 million in forfeiture, and at least $9.3 million to compensate affected patients after concealing a malfunction in its blood lead testing devices that produced inaccurately low lead test results, the U.S. Attorney’s Office for the District of Massachusetts announced today.
The company, based in Billerica, Mass., pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce, the department says.
According to the department, the charges stem from Magellan’s failure to notify the U.S. Food and Drug Administration (FDA) of a malfunction in its LeadCare Ultra and LeadCare II devices.
These devices, used to detect lead poisoning in children and adults, produced inaccurate results when testing venous blood samples.
Despite being aware of the malfunction as early as June 2013, Magellan released the devices to the market without informing the FDA or its customers, the department stated.