Three former executives of Magellan Diagnostics, a medical device company based in Billerica, Massachusetts, have been sentenced for their roles in concealing a malfunction in blood lead testing devices that resulted in inaccurate results for thousands of patients.
Amy Winslow, the company’s former CEO, was sentenced on October 27, 2025, to one year of home detention and ordered to pay a $10,000 fine after pleading guilty to one felony count related to the introduction of misbranded medical devices into interstate commerce. Hossein Maleknia, former COO, received nine months of home detention and a $20,000 fine following his guilty plea to two felony counts. Reba Daoust, who served as Director of Quality Assurance and Regulatory Affairs, was sentenced on November 21, 2025, to one year of probation with six months in home detention and a $600 fine after pleading guilty to making false statements.
The case centers around Magellan’s LeadCare II and LeadCare Ultra devices. These devices were widely used from 2013 through 2017 for detecting lead levels in children and adults using either venous or fingerstick blood samples. LeadCare II was responsible for more than half of all blood lead tests conducted nationwide during that period.
According to prosecutors, Winslow, Maleknia, and Daoust concealed from both customers and the Food and Drug Administration (FDA) a significant defect affecting the accuracy of test results when using venous blood samples. The malfunction led to thousands of patients—many of them children—receiving falsely low readings for blood lead levels.
“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 at the FDA Office of Criminal Investigations in New York. “We will continue to pursue and bring to justice those who endanger public health and safety.”
Ted E. Docks from the FBI Boston Division stated: “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. Their egregious conduct victimized vulnerable patients and eroded their trust in our healthcare system. The FBI is gratified all involved are being held accountable.”
Roberto Coviello from HHS-OIG added: “These three former executives deliberately concealed a known defect in medical devices used to detect lead poisoning—a condition with potentially irreversible consequences. 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 eventually determined that LeadCare devices could not reliably test venous samples; this finding prompted a recall on such uses along with warnings issued against using these devices for venous blood testing due to accuracy concerns.
Lead exposure poses serious health risks with no safe threshold according to information referenced by federal agencies including the Centers for Disease Control and Prevention (CDC). Children—particularly those living in older housing or low-income environments—and pregnant women are especially susceptible.
The announcement was made by U.S. Attorney Leah B. Foley along with officials from FDA-OCI, FBI Boston Division, HHS-OIG; Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin prosecuted this case.
