Blood Tests May Have ‘Significantly’ Underestimated Lead Levels, FDA Warns

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The tests the agency are warning about, though, are not used as often as less invasive screenings, so it should not affect most people, according to officials. However, pregnant women and children should be retested, they say.

The Washington Post: Blood Tests Significantly Underestimated Lead Levels, FDA And CDC Warn
Federal officials are warning that some blood tests may have “significantly” underestimated lead levels, and they are urging the retesting of some children, as well as pregnant and breast-feeding women. The Food and Drug Administration and the Centers for Disease Control and Prevention said the tests in question were made by Magellan Diagnostics, a Massachusetts-based testing company whose products are used in laboratories and doctors’ offices throughout the country. The problem may go as far back as 2014, the agency said. The warning applies only to tests in which blood samples are taken from a vein, not the more common, less invasive tests in which fingers or heels are pricked for a blood sample. (McGinley, 5/17)

The Wall Street Journal: FDA Warns On Magellan Diagnostics Lead Blood Tests
Dr. Patrick Breysse of the CDC estimated that fewer than 1% of lead tests performed on residents of Flint, Mich., were of the venous variety in question. In that city the water system was tainted with lead in a widely publicized case that led to criminal charges against city and state officials and an $87 million payout from the state to replace lead pipes. (Burton, 5/17)

NPR: Common Lead Test Can Give False Results, FDA Warns
The majority of lead tests are not conducted with that kind of blood sample, but rather blood from a heel or finger prick, says Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “We have no evidence that Magellan’s tests, when used with blood obtained from a finger or heel stick, are impacted,” says Shuren. “We believe most people will not be affected by this issue.” (Greenfieldboyce, 5/17)

The Baltimore Sun: Some Lead Tests Inaccurate, Health Officials Say
Meridian Bioscience, of which Magellan is a subsidiary, said the companies “take these matters very seriously and will continue to work closely and fully with the FDA and CDC to address the concerns identified with venous samples as quickly as possible.” (McDaniels, 5/18)

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