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Certain lead tests could produce faulty results - U.S. regulators
May 17, 2017 / 1:26 PM / 6 months ago

Certain lead tests could produce faulty results - U.S. regulators

May 17 (Reuters) - Certain tests used to detect lead exposure could provide inaccurate results for some children and adults in the United States, U.S. regulators warned on Wednesday.

The warning is based on data that indicates that the tests, made by Magellan Diagnostics, could throw up results that are lower than the actual level of lead in the blood, according to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

"The FDA is deeply concerned ... and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics' lead tests with blood drawn from a vein," Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement. (

Currently, the FDA believes the issue may date back to 2014, the agency said. (Reporting by Natalie Grover in Bengaluru; Editing by Maju Samuel)

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