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U.S. health agencies warn of inaccurate results from certain lead tests

Xinhua, May 18, 2017 Adjust font size:

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Wednesday warned that certain blood lead tests used in the country may be inaccurate.

The U.S. FDA said in a statement that laboratories and health care professionals should not use all four lead tests manufactured by a company called Magellan Diagnostics, including the LeadCare II system, a device "found in many doctors' offices and clinics" in the United States.

That's because all Magellan lead tests, when performed on blood drawn from a vein, may provide results that are lower than the actual lead level in the blood.

"The FDA is deeply concerned by this situation," said Jeffrey Shuren, 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."

The CDC recommended that health care professionals retest children younger than six years of age who were tested using any Magellan Diagnostics' LeadCare System tests and received a result of less than 10 micrograms per deciliter.

It also recommended that women, who are currently pregnant or nursing and were tested in this manner while pregnant or nursing, get retested.

Other adults who are concerned about their risk or the risk to an older child should speak to their doctors about whether they should be retested, it said.

Lead exposure can affect nearly every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues.

Lead poisoning is particularly dangerous to infants and young children, according to the U.S. CDC. Endit