Three former executives at Magellan Diagnostics Inc. are charged with knowingly selling defective lead testing machines between 2013 and 2017 that generated inaccurate results for tens of thousands of children across the country and for clients of at least one international relief organization, federal prosecutors said.
Amy Winslow, 51, of Needham; Reba Daoust, 66, of Amesbury; and Mohammad Hossein Maleknia,64, of Bonita Springs, Fla., are accused of knowing the devices — including its Leadclear II product that accounted for 2.5 million tests in 2017, half of all tests conducted in the United States — had a manufacturing flaw that generated false negatives, giving parents the mistaken impression their children were safe, US Attorney Rachael Rollins’s office said Wednesday.
“We allege that these defendants deceived customers and the FDA about the reliability of medical tests that detected lead levels. By doing so, we assert that they endangered the health and lives of incredibly vulnerable victims,” Rollins said in a statement. “According to the CDC, there is no safe level of lead in the blood.”
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