Magellan Diagnostics has agreed to plead guilty and pay $42 million for concealing a device malfunction for years that produced inaccurately low lead test results for potentially tens of thousands of children and other patients, including pregnant women.

The criminal charges concern tests used for fingerstick samples — accounting for more than half of all lead blood tests conducted in the US from 2013 through 2017 — and other tests for drawn blood.

The DOJ said that the company “has admitted that it misled its customers and the FDA about a serious malfunction” in the devices. “By hiding the malfunction and later deceiving customers and the FDA about when the company discovered the malfunction, the nature, extent and frequency of the malfunction, and the risks associated with the malfunction, Magellan caused an estimated tens of thousands of children and other patients to receive inaccurately low lead test results,” the DOJ said.

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