Tests for lead poisoning may be faulty, US regulators warn

Tests for lead poisoning may be faulty, US regulators warn

Federal officials warned Wednesday that results from certain lead tests manufactured by the company Magellan Diagnostics may have "significantly" underestimated how much lead was in the blood.

Children under 6 and pregnant and nursing women may need to be retested.

Still, Shuren said 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". The FDA believes the testing issue may date to 2014, but said the scope of the problem wasn't clear until March, when Magellan provided new information as part of the FDA's review of its newest lead test.

During a conference call with reporters, Shuren said Magellan got complaints about inaccurate results in 2014 but concluded after testing "that the risks were negligible" and took steps to resolve the issue. At present, all LeadCare systems can be used with blood from a finger or heel stick, including the LeadCare II system found in many doctors' offices and clinics.

However, on April 28, Magellan notified customers they should no longer use the blood collection tubes, and that they should also discontinue the 24-hour incubation method. Blood lead levels over this amount are considered especially serious, although there is no safe level of lead exposure for children. The same recommendation is being made for pregnant and nursing mothers.

FDA officials did not provide estimates of how many people may have been at risk for a faulty test. The most common way to check children's blood is through a finger or heel stick.

The agency "did not feel that the data was either adequate regarding what they thought may have been the cause of the problem, the extent of the problem or the effectiveness of the mitigation they put in place", the FDA's Shuren said.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the investigation was in its early stages, and that most people probably won't be affected. In Flint, Mich., for example, less than 1 percent of children tested for lead had blood samples taken from a vein, the officials said.

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. But if those levels are elevated, a follow up test is done with blood drawn from the arm.

Patrick Breysse, director of the CDC's National Center for Environmental Health, said, "We understand that parents of children and others affected by this problem will be concerned about what this means for their health".

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

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.