Testing Devices for Lead Used on Thousands of Children Found to Be Faulty

A firm specializing in lead poisoning testing has reached an agreement to settle charges of concealing a malfunction that led to inaccurately low results over an extended period.

In a move to resolve criminal charges, Magellan Diagnostics, based in Massachusetts, will pay $42 million in penalties, as announced by the Department of Justice.

Although the faulty devices were utilized between 2013 and 2017, some were subject to recalls as recent as 2021. The malfunction potentially affected the test results of “tens of thousands” of children and other patients, according to the Justice Department.

Medical practitioners emphasize that any amount of lead in the bloodstream, especially in children, is deemed unsafe. Various U.S. cities, including Washington, D.C., and Flint, Michigan, have grappled with significant lead contamination in their water systems in recent decades, underscoring the importance of accurate testing for public health.

There is a possibility that defective Magellan kits were used for lead exposure testing in children until the early 2020s, considering the recall in 2021. Here’s an overview for parents to be informed.

Which tests were impacted?

The flawed results stemmed from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. LeadCare II, predominantly utilizing finger-stick samples, constituted more than half of all U.S. blood lead tests between 2013 and 2017 and was frequently employed in physician offices to assess children’s lead levels.

The other two devices could also analyze blood drawn from a vein and were possibly more prevalent in laboratories than doctor’s offices. Magellan first identified a malfunction in its LeadCare Ultra device that could yield inaccurate results (specifically lowered lead test results) in June 2013 while seeking regulatory approval. However, this information was not disclosed as the company proceeded to market the tests, according to the settlement.

The agency revealed that testing in 2013 indicated a similar flaw in the LeadCare II device. A recall in 2021 encompassed the majority of the three types of test kits distributed since October 27, 2020.

In a press release regarding the settlement, the company affirmed that the issues affecting their products from 2013 to 2018 have been effectively resolved, and the current tests they offer are deemed safe.

What implications does a falsely low result have?

Children often undergo lead testing during pediatric visits at ages 1 and 2. Elevated lead levels can pose risks of developmental delays, reduced IQ, and other complications, potentially manifesting symptoms like stomachaches, poor appetite, or irritability only at higher levels.

Falsely low test results may have led to unawareness among parents and physicians about the issue.

Addressing lead poisoning primarily involves preventive measures initially. Results indicating elevated levels should prompt parents and health authorities to identify lead sources and prevent further lead exposure, noted Janine Kerr from the Virginia Department of Health’s Childhood Lead Poisoning Prevention Program.

Children can come into contact with lead through various means, including drinking water with lead contamination from aging pipes, ingesting lead-based paint chips prevalent in older homes, or, as recently disclosed, consuming specific brands of cinnamon-flavored applesauce.

What actions should parents take now?

Parents are advised to consult their child’s pediatrician to verify if a blood lead test using a LeadCare device was conducted and discuss the necessity of a repeat test, as suggested by Maida Galvez, a pediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York.

During a prior recall of certain Magellan devices in 2017, the Centers for Disease Control and Prevention recommended retesting for pregnant individuals, nursing mothers, or children under 6 with blood lead levels below 10 micrograms per deciliter from a venous blood draw using a Magellan device.

The 2021 recall urged retesting for children with results below the current CDC reference level of 3.5 micrograms per deciliter, with many tests being of the finger-stick type.

The Virginia health department has reported minimal inquiries regarding the recall, with Kerr mentioning that finger-stick tests are not extensively utilized in Virginia but acknowledged significant interest in the applesauce recall.

In any event, seeking guidance from a healthcare provider is recommended for parents.