Magellan Diagnostics: Falsely Low Lead Tests, With the Malfunction Kept Quiet

The Magellan Diagnostics LeadCare guilty plea concerned falsely low blood-lead results and a malfunction the company admitted hiding from customers and the Food and Drug Administration. In its criminal case summary, the Justice Department said Magellan knew about the malfunction before releasing devices to the market. The company also misled customers and regulators about when it discovered the problem. For someone inside testing, quality or regulatory affairs, that difference between what the company knew and what it said is the heart of the case.

Magellan, a medical device company headquartered in Billerica, Massachusetts, made tests used to detect lead in the blood of children and adults.

What LeadCare Was Supposed to Measure

LeadCare measured blood-lead levels using either blood drawn from an arm or a fingerstick sample. The distinction matters because the malfunction described in the criminal case affected venous samples, the blood drawn from an arm.

LeadCare II was predominantly used for fingerstick testing. LeadCare Ultra and LeadCare Plus were predominantly used for venous samples. LeadCare II accounted for more than half of all blood-lead tests conducted in the United States from 2013 through 2017.

The error ran in one direction: the devices could make a patient’s lead level look lower than it was. The Justice Department’s account of the executive pleas cites court documents explaining that lead exposure can cause irreversible physical and mental health problems and that young children and pregnant women are especially vulnerable.

The Company Knew Before the Devices Reached Customers

The Justice Department’s criminal case summary reports Magellan’s admission that it released devices to the market in 2013 after learning of the malfunction, without telling customers or the Food and Drug Administration. The Justice Department specifically identified LeadCare Ultra and LeadCare II in that admission.

The concealment continued beyond the decision to release the products. The same criminal case summary says Magellan later deceived customers and regulators about when the malfunction was discovered, how extensive and frequent it was, and the risks it posed.

The discovery date connects technical knowledge to a business decision. Comparing dated testing with the company’s later explanation can show whether that explanation matches what employees already knew. That is where a testing employee’s view becomes valuable: the work predates the account eventually given to the customer.

The Justice Department’s criminal case summary estimated that tens of thousands of children and other patients received inaccurately low results because of the concealment and deception. The Food and Drug Administration ultimately found that the LeadCare devices could not accurately test venous samples. That finding led to a recall of LeadCare devices for venous use and a public warning against using LeadCare Ultra, LeadCare II and LeadCare Plus with venous blood samples.

Why the Manufacturer’s Reporting Decisions Matter

A device manufacturer sits where reports from customers and importers meet the company’s own technical knowledge. In the reporting system, user facilities send serious-injury reports to the manufacturer when the manufacturer is known, and importers send malfunction reports to the manufacturer. The company selling the product also helps determine what the regulator learns about its failures.

The reporting judgment includes whether a malfunction would be likely to cause or contribute to death or serious injury if it happened again. Testing and analysis belong in that judgment. A pattern in complaint data can also make the need for corrective action apparent. An employee who sees the pattern may understand something that no single customer can see.

The internal decision about whether to report a malfunction is a useful part of an investigation alongside the report that eventually reaches the Food and Drug Administration. Our review follows what information reached the company, what it learned through testing, and how it explained its decision.

For a LeadCare-type problem, we would compare the affected model and sample type across the testing, customer communications and regulatory account.

Alere Shows What an Internal Complaint File Can Reveal

In Alere’s Triage case, the whistleblower’s complaint alleged suppressed adverse-event reporting by comparing internal complaint counts with reports in the Food and Drug Administration’s public database.

The Executive Pleas Followed Different Roles

The Justice Department announced in March 2025 that Magellan’s former chief executive, chief operating officer and director of quality assurance and regulatory affairs had pleaded guilty in connection with concealing the malfunction.

The former chief executive and chief operating officer pleaded guilty to distributing misbranded medical devices across state lines. The former quality and regulatory director pleaded guilty to making false statements.

In its announcement of those criminal pleas, the Justice Department said the executives misled customers and the Food and Drug Administration about the venous-sample malfunction, its discovery, its extent and its risks. The product sent to customers and the information sent to the government were both part of the conduct described in the criminal case.

What Evidence Is Needed to Prove Fraud?

For a case involving concealed diagnostic failures, we connect product testing and internal knowledge with what customers and regulators were told. For a civil whistleblower case under the False Claims Act, we also examine how that conduct reached requests for government payment.

The 2020 Journal of Forensic and Investigative Accounting paper A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud explains why investigators examine both false claims and the conduct that causes someone else to submit them.

A quality employee may know the test results or complaint history. Someone dealing with customers may know the explanation they received. Someone working with health care payments may see the testing claims. We work with the insider to connect those parts of the business and assess the strongest case the evidence supports.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Saw the Results Before the Explanation

If you know how a diagnostic company handled failed testing, customer complaints or a changed account to the Food and Drug Administration, tell our whistleblower experts what you saw. We build the case with you and bring in medical device fraud whistleblower lawyers who understand the connection between product failures, concealed information and government payments. We stay beside you as that inside knowledge becomes the foundation of your case.