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Blood Tests May Report Inaccurate Lead Levels, FDA Warns

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Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention warn consumers that some blood tests may have “significantly” underestimated the lead levels present in samples. They urge children, pregnant, and breast-feeding women to get retested.

The tests in question were manufactured by Magellan Diagnostics, a testing company based in Massachusetts. The blood tests are used in laboratories and clinics throughout the USA, The Washington Post reports. This problem may even go back to as far as 2014, the agencies said.

This only applies to blood samples that are taken from a vein, and not the common tests that require a prick on the fingers or heels.

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the FDA investigation is currently in its early phases, so most people are not likely to be affected. But he remains deeply concerned because a “root cause” of the problem has not yet been found.

The FDA and the CDC recommend that young children under six years old get retested if their Magellan venous tests showed lead levels of less than 10 micrograms per deciliter. Pregnant and nursing women should likewise get rechecked, and other adults who might have a reason to worry about lead exposure should talk to their doctors.

Magellan is working closely with the FDA to address the situation, and is offering finger-stick testing instead of venous tests.

Every year, around 300,000 vein-based tests are performed in labs using Magellan products, and over 2.5 million are done in doctors’ offices.

Patrick Breysse, director of the CDC’s National Center for Environmental Health, said that the CDC has kept a careful eye on communities where the water is contaminated with lead. He added that “less than 1 percent” of children in places like Flint, Michigan, might be at risk due to the inaccurate lead blood test reporting.

Tim Hill, an official with the Centers for Medicare and Medicaid Services, said that Medicaid would pay for retesting children, and that people with private insurance should approach their providers regarding the matter.

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