According to an investigation led by the Food and Drug Administration (FDA), the Magellan venous blood testing system has reportedly misrepresented lead levels in blood tests across the United States. The Centers for Disease Control and Prevention (CDC), recommends that pregnant mothers who have used the Magellan system be retested, as well as children under the age of six who’ve had blood test results of ten micrograms of lead or less per deciliter of blood.
An Understated Truth
The manufacturer of the Magellan venous blood test system, Magellan Diagnostics, is currently under investigation and the FDA and CDC report that the problem may have started as far back as 2014. Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, stated in a conference call that the “root cause” of the Magellan testing defect has not been determined yet, though the investigation is still in its early phases. Magellan, a Massachusetts based company, currently has products in use around the country that make up for 300,000 venous blood tests each year.
The FDA claims that Magellan received complaints regarding the accuracy of its venous blood testing system in 2014, and that Magellan deemed that “the risks were negligible” and the inaccuracy could be solved by delaying processing for 24 hours, according to the investigation. In 2015, Magellan submitted a malfunction report to the FDA, while claiming that the incident was “not likely to cause adverse health consequences.”
According to Shuren, the FDA did not become concerned about Magellan blood tests until April, 2017, when the company requested a label change. To do so, Magellan would need to pass a common standard in FDA clearance by demonstrating that their product was as safe and effective — and in this case accurate — as another similar product that is currently on the market.
The Effect of Inaccurate Blood Tests
Though the Magellan venous blood test is under investigation, there are still other, more common, forms of blood tests available. Typically, and especially in the case of children, blood testing for lead is conducted with a finger or heel prick known as a “capillary test.” It’s only when a capillary test shows elevated levels of lead that a doctor would use a venous test to confirm the results.
Centers for Medicare and Medicaid official, Tim Hill, stated that Medicaid would cover the costs for retesting children on the program, and that those who are covered by private insurance should ask their health plan providers about retesting.
Director of CDC’s National Center for Environmental Health, Patrick Breysse, stated that the agency is keeping an eye on populations in areas like Flint, Michigan, where the chances of lead poisoning are more likely than other parts of the country. Though Breysse also estimated that “less than one percent” of children in Flint would be at risk for inaccurate blood test results.