Federal health officials say blood tests manufactured by Magellan Diagnostics "significantly" underreported lead levels in patients as far back as 2014, reports The Washington Post.
Here are four things to know.
1. Billerica, Mass.-based Magellan Diagnostics provides diagnostic tests and supplies to laboratories and physician offices nationwide, according to the report.
2. The Food and Drug Administration and the CDC contend the company's vein-based blood tests produce inaccurate lead level results. Magellan tests using blood from a finger or heel prick produce accurate results, the agencies said.
3. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said the agency is still in the early stages of investigating the faulty blood tests. While he said the issue probably won't affect many people, he was still concerned about inaccuracies and the lack of knowledge surrounding a root cause for the faulty blood tests, according to The Washington Post.
4. The CDC and FDA urge some children — and women who are pregnant or breast-feeding — who previously took a vein-based Magellan blood test to get retested. John Kraeutler, CEO of Magellan's parent company, Meridian Bioscience, said the company is working closely with the FDA to resolve the issue. The company is also offering to shift customers from vein-based testing to finger-prick testing, reports The Washington Post.
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