Source: United States Department of Justice Criminal Division
BOSTON – The former CEO, COO and Director of Quality Assurance and Regulatory Affairs for Magellan Diagnostics, Inc. (Magellan), a medical device company headquartered in Billerica, Mass., have been sentenced in federal court in Boston for concealing a device malfunction that produced inaccurately low lead test results for thousands of children and other patients.
Amy Winslow, 54, of Needham, Mass., was sentenced on Oct. 27, 2025 by U.S. Senior District Court Judge Patti B. Saris to one year of home detention. Winslow was also ordered to pay a $10,000 fine. In March 2025, Winslow pleaded guilty to one felony count of introduction of misbranded medical devices into interstate commerce.
Hossein Maleknia, 66, of Bonita Springs, Fla., was sentenced by Judge Saris on Oct. 30, 2025 to nine months of home detention. Maleknia was also ordered to pay a $20,000 fine. In March 2025, Maleknia pleaded guilty to two felony counts of introduction of misbranded medical devices into interstate commerce.
On Nov. 21, 2025, Reba Daoust, 69, of Amesbury, Mass., was sentenced by Judge Saris to one year of probation, with the first six months to be served in home detention. Daoust was also ordered to pay a $600 fine. In March 2025, Daoust pleaded guilty to one felony count of making false statements.
Magellan’s LeadCare II and LeadCare Ultra devices detected lead levels and lead poisoning in the blood of children and adults using either venous (i.e. blood draws through the arm) or fingerstick samples. 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 Ultra was predominantly used to test venous samples.
Winslow, Maleknia and Daoust – Magellan’s former CEO, COO and Director of Quality Assurance and Regulatory Affairs, respectively – misled Magellan customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices when they were used to test venous blood samples. By hiding the malfunction and later misleading customers and the FDA about when they discovered the malfunction, the nature, extent and frequency of the malfunction, as well as the risks associated with the malfunction, the defendants caused an estimated thousands of children and other patients to receive inaccurately low lead test results.
“These defendants knowingly misled the FDA about a device malfunction that caused thousands of children and adults to receive inaccurate blood lead test results. They understood the risks: that patients could receive falsely low readings, when their actual blood lead levels met or exceeded CDC intervention thresholds. They knew this failure could delay critical care, allow continued lead exposure and endanger the health of vulnerable families. Yet they chose to conceal the truth, prioritizing corporate profits, job security, and personal gain over patient safety. Regardless of the sentences imposed, their actions jeopardized the wellbeing of thousands,” said United States Attorney Leah B. Foley. “We will continue to uncover and prosecute those who violate the public’s trust and put public health at risk.”
“Individuals and companies whose lead testing devices produce inaccurate results can put the health of all patients, especially vulnerable children, at significant risk,” said Fernando McMillian, Special Agent in Charge, FDA Office of Criminal Investigations, New York Field Office. “We will continue to pursue and bring to justice those who endanger public health and safety.”
“Misleading consumers and federal regulators about a significant flaw in a medical device to boost your company’s bottom line is reprehensible. These three executives did exactly that, and in the process ignored the well-being of thousands of children and other patients who received inaccurate test results of the lead levels in their blood,” said Ted E. Docks, Special Agent in Charge of the Federal Bureau of Investigation, Boston Division. “Their egregious conduct victimized vulnerable patients and eroded their trust in our healthcare system. The FBI is gratified all involved are being held accountable.”
“These three former executives deliberately concealed a known defect in medical devices used to detect lead poisoning—a condition with potentially irreversible consequences,” said Roberto Coviello, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General. “The criminal sentences announced today mark an important step toward justice for the thousands of children and vulnerable patients who were put at risk by the corrupt actions of these defendants.”
The FDA ultimately found that the LeadCare devices could not accurately test venous samples, leading to a recall of all LeadCare devices using venous samples and a warning to the public not to use the devices for venous blood samples because of the malfunction.
According to court documents, as referenced by the Centers for Disease Control and Prevention, there is no safe level of lead in the blood. Lead exposure may cause irreversible lifelong physical and mental health problems. Young children and pregnant women are most vulnerable to lead exposure, especially those from low-income households and those who live in housing built before 1978 because those homes are more likely to contain lead-based paint and have fixtures containing lead.
U.S. Attorney Foley, FDA-OCI SAC McMillan, FBI SAC Docks and HHS-OIG SAC Coviello made the announcement. Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin of the Health Care Fraud Unit prosecuted the case.