FDA warns of faulty lead tests

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.

Officials are recommending retesting for certain children, pregnant women and nursing mothers who did get tested using blood from a vein.

But Shuren said the investigation is still in its early stages and the agency has not determined the root cause of the inaccurate results.

The FDA's warning is based on now 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.

Shuren said that the FDA first became aware of the issue during a review of a 510 (k) premarket submission for a new LeadCare product received from Magellan in March 2017.

"We have no evidence that Magellan's tests, when used with blood obtained from a finger or heel stick, are impacted", says Shuren. The blood tests are used in laboratories and clinics throughout the USA, The Washington Post reports.

The tests have been in use since 2014, the start of Flint's lead in water crisis, during which blood testing for adults and children concerned about lead exposure was routine.

FDA officials did not provide estimates of how many people may have been at risk for a faulty test.

It is unclear why Magellan lead tests perform differently with venous blood than with capillary blood from a finger or heel stick, FDA said.

Registered Nurse Brian Jones draws a blood sample from Grayling Stefek, 5, at the Eisenhower Elementary School, Tuesday, Jan. 26, 2016 in Flint, Mich. Although the majority of children tested were subject to a finger prick or a heel stick, a small percentage had blood drawn from a vein.

According to the FDA's statement, Magellan initially recognized the possible problem during the performance of their LeadCare Ultra -one of the trials- in August 2014 and they notified customers by letter on November 2014.

Doctors say pregnant and nursing women, as well as kids under the age of 6 should ask their doctors if they should be retested. It can cause serious long-term health problems - even at low levels - including reduced intelligence, impaired hearing and irritability. If such results find elevated lead levels, the results are confirmed through a venous blood test.

If you fall into any of those categories, the CDC recommends you talk to your doctor or another healthcare professional about whether or not you should be retested.

Lead exposure doesn't cause noticeable symptoms, however it can damage childrens' IQ.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the FDA investigation is now in its early phases, so most people are not likely to be affected.

Since a year ago, Reuters has identified more than 3,300 US neighborhood areas with documented childhood lead poisoning rates double those found in Flint, Michigan.


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