The FBI’s Boston Division is seeking information about persons who may have been harmed by the delayed detection of lead poisoning or lead exposure due to a malfunction in blood lead testing devices manufactured by Magellan Diagnostics, Inc.

Magellan’s devices—LeadCare Ultra, LeadCare II and LeadCare Plus—detected lead levels and lead poisoning in the blood of children and adults using either venous (i.e., blood draws through the arm) or fingerstick samples. LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2017. LeadCare Plus and LeadCare Ultra were predominantly used to test venous samples.

Magellan has admitted that it misled its customers and the FDA about a serious malfunction that affected Magellan’s LeadCare devices when they were used to test venous blood samples. By hiding the malfunction and later deceiving customers and the FDA about when the company discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, Magellan caused an estimated tens of thousands of children and other patients to receive inaccurately low 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 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.

As part of a resolution of criminal charges, Magellan has agreed to compensate all patients who were demonstrably harmed for the pecuniary damages they suffered as a result of the delayed detection of lead poisoning or lead exposure due to the malfunction in Magellan’s LeadCare blood lead testing devices. If you believe you and/or your minor dependent(s) received an inaccurate lead test from a LeadCare device, 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, compensation, and rights under federal and/or state law. Your responses are voluntary but may be useful 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.