BOSTON, Mass. (WWLP)-- A Massachusetts medical device company has been found guilty for criminal charges related to the concealment of a device malfunction that produced inaccurately low lead test results. Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass. pleaded guilty to two counts of introducing a misbranded medical device into interstate commerce. The company was ordered to pay a $21.8 million fine, $10.9 million in forfeiture and a minimum of $9.3 million to compensate patient victims. Former executives of Massachusetts company charged after malfunction of devices caused inaccurate lead tests Magellan’s devices, LeadCare Ultra, LeadCare II and LeadCare Plus, detected lead levels and lead poisoning in the blood of children and adults. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Plus and LeadCare Ultra were predominantly used to test samples from blood draws from the arms. According to court documents, Magellan failed to timely notify the FDA about a serious malfunction that caused the company’s LeadCare devices to produce inaccurate blood lead level results when used to test venous blood samples. The company also changed the user instructions for the LeadCare devices without prior FDA notice or approval. Magellan knew of the LeadCare Ultra malfunction during the FDA clearance process in June 2013, but released the device later that year without notifying the FDA or customers. Many of those customers reported the malfunction. “Medical device makers have an obligation to provide truthful information to protect patients. By deliberately concealing and consistently misleading consumers and the FDA about device malfunctions, Magellan acted with gross disregard for its responsibility to comply with FDA requirements and put patients at risk,” said Fernando McMillian, Special Agent in Charge, FDA Office of Criminal Investigations, New York Field Office. “We will continue to thoroughly investigate those whose actions undermine the integrity of the FDA regulatory process which exists to protect consumer health.” “It’s absolutely appalling that Magellan Diagnostics was more concerned about its bottom line than it was about coming clean to their customers and the FDA about a serious malfunction in its lead testing devices that we believe unnecessarily endangered the health of incredibly vulnerable victims,” said Jodi Cohen, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “When you’re not feeling well, and you’re trying to find out why, the last thing you should have to worry about is whether the diagnostic test you’re relying on lives up to its manufacturer’s claims. The FBI is grateful to see that the victims affected by Magellan’s actions in this case are one step closer to being compensated.” “Magellan concealed a serious flaw in its lead testing devices while ignoring the well-being of patients and knowingly providing inaccurate results of lead levels in the blood,” said Roberto Coviello, Special Agent in Charge of the U.S. Department of Health and Human Services, Office of Inspector General. “This type of egregious conduct, which only sought to benefit the corporate bottom line, can erode the public’s trust in our nation’s health care system. Today’s sentencing should send a clear message that any company engaging in such dangerous activity will be held accountable.” In April 2023, three former executives of the company were charged with conspiracy, wire fraud, and FDA violations in connection with concealing a device malfunction. If you or a family member believe you received an inaccurate blood lead test result from a LeadCare device between 2013–2017, fill out the questionnaire located on the FBI’s website. Information about the status of the case is located on the U.S. Attorney’s Office website.