Federal health officials are warning that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults.
The U.S. Centers for Disease Control and Prevention (CDC) says children under six, as well as currently pregnant women and nursing mothers, may need to be retested.
“The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health for the Food and Drug Administration (FDA).
The FDA’s warning yesterday is based on currently available data that indicate Magellan lead tests – when performed on blood drawn from a vein – may provide results that are lower than the actual level of lead in the blood.
Tests taken on blood drawn from a finger or heel prick were not found to be providing inaccurate results, the FDA said.
It’s an issue of concern in Baltimore, where hundreds of children are still being poisoned every year, and across the country, where nearly half a million children suffer from lead poisoning, most living in old houses in low-income communities.
Lead poisoning can cause cognitive deficits and severely affect other functions in the body.
Lead Still Poisoning Baltimore
Lead paint was banned in 1950 in Baltimore, decades earlier than in the rest of the country. Activism here in the 1980s led to the national Coalition to End Childhood Lead Poisoning and the Green and Healthy Homes Initiative.
Lead paint cases in the city dropped dramatically in the wake of those efforts.
But the disclosure in 2015 that Freddie Gray had extremely high blood lead levels as a child drew attention to the persistence of the problem, with children in the city’s predominantly African-American neighborhoods continuing to be exposed.
Activists have said the government leaders and policy makers need to do more to force landlords to fix the problem and to recognize that any level of lead is harmful to children.
As part of Baltimore’s effort to combat the problem, Health Commissioner Leana Wen has sought funding to get more instant testing into doctors’ offices, she told National Public Radio last year.
“A primary care doctor may recommend that the child is tested,” Wen told NPR. “However, by the time that parent goes to a lab and then gets that report back, some kids may fall through the cracks during that time.”
The Magellan Diagnostic testing has been popular because it can be tested right away and does not have to be sent off to a lab.
Who Should be Tested
Warning that the issue dates back to 2014, the FDA said yesterday that all four of Magellan Diagnostic’s lead testing systems were affected: LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra.
The CDC warning said a health professional should be consulted and testing redone for:
• Children under six whose test was conducted using blood drawn from a vein using any Magellan Diagnostics’ LeadCare System tests and received a result of less than 10 micrograms per deciliter (µg/dL).
• Women who are currently pregnant or nursing and were tested in this manner while pregnant or nursing.
“While most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care,” said Patrick Breysse, director of the CDC’s National Center for Environmental Health.
FDA: Company Underestimated Risk
The FDA’s Shuren told the New York Times that the Massachusetts-based company knew about the problem as far back as 2014, but considered it “no big deal.”
“It wasn’t until we started to ask more questions of the company, to peel back the onion, that we found the company had underestimated the amount of risk to the public,” Shuren said.
The company “did not have adequate data and supporting documentation regarding the cause of the problem and the effectiveness of the mitigation they had put in place in the past,” he said.