FDA Warns on Magellan Diagnostics Lead Blood Tests

Certain tests for lead in the blood give inaccurately low results



A nurse draws the blood to test for lead poisoning in downtown Flint, Mich., on Jan. 23, 2016.  PHOTO: BRETT CARLSEN/GETTY IMAGES

By

Thomas M. Burton


WASHINGTON—The Food and Drug Administration and the Centers for Disease Control and Prevention warned Wednesday that certain tests for lead in the blood give inaccurately low results and said some children and pregnant or breast-feeding women should be retested.

At issue are tests for lead in blood taken from people’s veins, made by Magellan Diagnostics Inc. of North Billerica, Mass. Federal officials said that while the company has sold millions of tests in recent years, the great majority of them are heel-stick or finger-stick tests, and not of the type reported as inaccurate.

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.

“We believe that most people will not be affected,” said Jeffrey Shuren, director of the FDA’s medical-device center. But he said the agency nevertheless “is warning laboratories and health-care professionals that they should not use any Magellan Diagnostics lead tests with blood drawn from a vein.”

Dr. Shuren said Magellan began to receive complaints in 2014 but “regarded this as low-risk” and didn’t notify the FDA at the time. He said the agency still is working to try to assess the full scope of the problem.

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