FDA officials 'deeply concerned' about inaccurate lead exposure tests

FDA officials 'deeply concerned' about inaccurate lead exposure tests
Posted at 9:56 AM, May 17, 2017

Some lead tests manufactured by Magellan Diagnostics may be providing inaccurate results.

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans about this test, recommending "parents of children younger than six years of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they should be retested."

A press announcements from the FDA says the following:

“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.

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"The FDA’s warning is based on currently available data that indicate Magellan lead tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood." 

The issue may date back to 2014, the FDA's announcement says.

"The warning includes all four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. At this time, all LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system — a system found in many doctors’ offices and clinics. In addition, some laboratories offer other methods of lead testing, which are not believed to be affected at this time.

"The CDC is recommending that health care professionals retest children younger than six years (72 months) of age at the time of this alert (May 17, 2017) if their test was conducted using blood drawn from a vein using any Magellan Diagnostics’ LeadCare System tests and received a result of less than 10 micrograms per deciliter (µg/dL)."