FDA Warns Americans about Inaccurate Lead Test Results

The CDC is recommending retesting for children, pregnant women and nursing mothers

According to a news release, the FDA and CDC are warning Americans that lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults. Parents of children younger than six years, pregnant women and nursing mothers who have been tested for lead exposure have been encouraged to seek professional advice regarding retesting.

“The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”

Data incidates Magellan tests may provide results that are lower than the actual level of lead in the blood, an issue that dates back to 2014.

“We understand that parents of children and others affected by this problem will be concerned about what this means for their health,” said Patrick Breysse, Ph.D., director of the CDC’s National Center for Environmental Health. “While most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care. For this reason, because every child’s health is important, the CDC recommends that those at greatest risk be retested.”

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