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Home Seeking Information in Magellan Diagnostics Investigation

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.

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1. I am filing this form out on behalf of:

2. If filling out this form for a minor dependent(s), please provide the minor dependent’s first name, last name, and date of birth
3. Did you or your minor dependent receive a blood lead test between January 2013 and May 2017?

4. Do you know how the blood was drawn for the lead test?

5. Do you believe the blood lead test result was inaccurate?

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8. Do you know what device was used to conduct the blood lead test?

9. Were you or your minor dependent retested after the initial blood lead test?

10. Was the retested blood lead result higher?

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Privacy Act Statement

The FBI is authorized to collect the information on this form by one or more of the following provisions: Title 28, United States Code, sections 533 and 534; Title 28, Code of Federal Regulations, section 0.85; and the Attorney General Guidelines for Victim and Witness Assistance. The information requested will assist the FBI in providing you with assistance to which crime victims are entitled under federal law. You do not have to provide the requested information; however, failure to do so may hinder the FBI in providing you with crime victim assistance. The information collected on this form is protected by the Privacy Act of 1974, as amended, Title 5, United States Code section 552a, and is maintained in the FBI’s Central Records System, DOJ/FBI-002, a description of which was published in the Federal Register at 63 Fed. Reg. 8671 (Feb. 20, 1998) and which may be viewed at