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FDA Warns of Inaccurate Results From Certain Lead Tests

THURSDAY, May 18, 2017 -- Lead tests made by Magellan Diagnostics may yield inaccurate results for some children and adults, U.S. health officials warned Wednesday.

Parents of children younger than 6 years old, pregnant women, and nursing mothers who have been tested for lead exposure using these tests should consult a health care provider about whether they should be retested, the officials said.

Data indicate that when all four of Magellan's lead testing systems -- LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra -- are performed on blood drawn from a vein, they may give results that are lower than the actual level of lead in the blood.

"The FDA is concerned that Magellan lead tests that use blood drawn from a vein may provide results that are lower than the actual level of lead in the blood," Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, said during a media briefing. "There is little evidence that Magellan tests using blood from a finger or heel stick are affected."

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Posted: May 2017

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