BOSTON – In a shocking revelation, Magellan Diagnostics, Inc., a medical device company based in Billerica, Massachusetts, has agreed to plead guilty to concealing a device malfunction that produced inaccurately low lead test results for tens of thousands of children and other patients.
As part of the resolution, Magellan will plead guilty to violations of the federal Food, Drug and Cosmetic Act and pay a $21.8 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims. The company has also agreed to a deferred prosecution agreement to resolve felony conspiracy fraud charges.
The malfunction affected Magellan’s LeadCare Ultra, LeadCare II, and LeadCare Plus devices, which detected lead levels and lead poisoning in the blood of children and adults using venous or fingerstick samples. The devices were predominantly used to test venous samples, with LeadCare II accounting for more than half of all blood lead tests conducted in the United States from 2013 to 2017.
According to 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, particularly in young children and pregnant women.
Magellan first learned about the malfunction in June 2013 during the FDA clearance process but released LeadCare Ultra to the market in December 2013 without informing customers or the FDA. The company misled its customers and the FDA about the malfunction, causing an estimated tens of thousands of children and other patients to receive inaccurately low lead test results.
Magellan’s testing in 2013 also indicated that the same malfunction affected the LeadCare II device, which was the company’s highest-revenue product. The company did not notify its customers and the FDA about the LeadCare II malfunction until November 2016.
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 LeadCare Ultra, LeadCare II, and LeadCare Plus for venous blood samples because of the malfunction.
Defendant/Respondent: Magellan Diagnostics, Inc.
Criminal Charges: Violations of the federal Food, Drug and Cosmetic Act; felony conspiracy fraud charges
City and State: Billerica, Massachusetts
Exact Date: April 28, 2026
Sentence/Outcome: Agreed to plead guilty and pay $42 million in fines and restitution
Dollar Amounts: $21.8 million fine, $10.9 million in forfeiture, and a minimum of $9.3 million to compensate patient victims
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Key Facts
- State: Massachusetts
- Category: Healthcare Fraud
- Source: DOJ Press Release â†â€â€
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