THREE FORMER MAGELLAN DIAGNOSTICS EXECUTIVES SENTENCED FOR HIDING DEVICE MALFUNCTIONS THAT PUT THOUSANDS AT RISK

FDA and federal investigators say concealed defects in lead-testing devices caused dangerously inaccurate results for children and other vulnerable patients

Federal prosecutors announced the sentencing of three former senior executives of Magellan Diagnostics, Inc., a Massachusetts-based medical device company whose lead-testing machines produced dangerously inaccurate results for thousands of children and adults nationwide. The court found that the executives concealed a serious malfunction in Magellan’s LeadCare diagnostic systems, misleading customers, federal regulators, and the FDA while the devices continued to be used in clinics across the country.

The former CEO, Amy Winslow, 54, of Needham, was sentenced to one year of home detention and fined $10,000. Former COO Hossein Maleknia, 66, of Bonita Springs, Florida, received nine months of home detention and a $20,000 fine. Reba Daoust, 69, Magellan’s former Director of Quality Assurance and Regulatory Affairs, was sentenced to one year of probation with six months of home detention, and fined $600. All three defendants pleaded guilty in March 2025 to felony charges related to misbranding medical devices and making false statements.

At the center of the case were Magellan’s LeadCare II and LeadCare Ultra systems, devices used for blood lead testing from both venous draws and fingerstick samples. LeadCare II alone accounted for more than half of all blood-lead tests in the United States between 2013 and 2017, making the reliability of these devices critical for public health. But according to prosecutors, the company’s leadership became aware of a malfunction that caused venous blood samples to generate dangerously low — and therefore misleading — lead readings.

Instead of disclosing the defect, federal investigators say Winslow, Maleknia, and Daoust concealed it, minimized its significance, and misrepresented the timeline and severity of the issue to both customers and the FDA. By doing so, they allowed clinics, pediatricians, hospitals, and public health agencies to rely on results that did not reflect patients’ true lead exposure levels.

The consequences were far-reaching. Thousands of children and vulnerable patients received blood-lead test results that appeared normal but were, in fact, artificially low. These inaccurate readings could have delayed diagnosis, postponed medical intervention, and prolonged exposure to lead — a toxin with irreversible neurological and developmental impacts, especially in young children.

U.S. Attorney Leah B. Foley condemned the executives’ actions, stating that they “knowingly misled the FDA about a device malfunction that caused thousands of children and adults to receive inaccurate blood lead test results.” Foley emphasized that the defendants understood exactly what was at stake: patients who met or exceeded CDC intervention thresholds were told they were safe, potentially continuing exposure without treatment.

FDA-OCI Special Agent in Charge Fernando McMillian stressed that any company producing inaccurate or unreliable lead-testing devices “puts the health of all patients, especially vulnerable children, at significant risk.” The FDA ultimately determined that LeadCare devices could not safely or accurately test venous samples, leading to a nationwide recall and an alert instructing providers to stop using the devices for venous blood testing.

FBI Special Agent in Charge Ted E. Docks called the misconduct “reprehensible,” noting that the executives placed corporate gain above public safety, eroding trust in the healthcare system while enabling continued exposure to a toxic metal known to cause permanent harm. HHS-OIG SAC Roberto Coviello said the sentences represent “an important step toward justice for the thousands of children and vulnerable patients who were put at risk.”

The Centers for Disease Control and Prevention reiterates that no level of lead exposure is considered safe, and long-term or unaddressed exposure can cause irreversible physical, cognitive, and developmental damage. Low-income families and those living in older homes remain disproportionately affected.

The case was prosecuted by Assistant U.S. Attorneys Leslie Wright and Mackenzie A. Queenin of the Health Care Fraud Unit.

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