April 5, 2023

Seeking Information in Magellan Diagnostics Investigation

The FBI’s Boston Division is seeking information in the investigation of three former senior executives for Magellan Diagnostics. 

The indictment alleges that from June 2013 through December 2017, the defendants repeatedly misled customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices—LeadCare Ultra, LeadCare II, and LeadCare Plus. By allegedly hiding the malfunction and later deceiving customers and the FDA about when they discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, the defendants allegedly caused an estimated tens of thousands of children and other patients to receive inaccurate lead test results. 

In other words, patients who were tested with a LeadCare device from 2013 through 2017 may have received results that were inaccurate—for example, a patient’s blood lead level may have been above the CDC-recommended initial threshold of concern of 5 micrograms per deciliter (μg/dL), but the LeadCare device reported a blood lead level below 5 μg/dL. 

In 2017, the FDA ultimately found that the LeadCare Devices should not be used with venous samples, leading to a recall of all LeadCare Devices using venous samples.  At the time, the Centers for Disease Control and Prevention (CDC) recommended that patients should be retested for blood lead levels if they are (a) younger than 6 years old and (b) previously had a venous blood test result of less than 10 µg/dL analyzed using a Magellan Diagnostics’ LeadCare device. 

According to court documents, as referenced by the CDC, 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.

If you believe you and/or your minor dependent(s) received an inaccurate lead test from a LeadCare device, or that you have information pertinent to this investigation, please fill out this short form.

The FBI is legally mandated to identify victims of federal crimes it investigates. Victims may be eligible for certain services, restitution, and rights under federal and/or state law. Your responses are voluntary but may be useful in the federal investigation and to identify you as a potential victim. Based on the responses provided, you may be contacted by the FBI and asked to provide additional information. All identities of victims will be kept confidential.