DOJ: Former Magellan quality control director, execs misled public over lead tests
By 
Adrianne Appel2023-04-11T18:50:00
The former director of quality assurance at Magellan Diagnostics conspired with executives to conceal a critical flaw in lead tests they knew would result in tens of thousands of false negative tests among lead-exposed children, according to the Department of Justice (DOJ).
Reba Daoust, former Magellan director of quality assurance and regulatory affairs; Amy Winslow, former chief executive officer; and Hossein Maleknia, former chief operating officer, repeatedly misled health clinics and the Food and Drug Administration (FDA) about the accuracy of lead-testing devices made by market leader Magellan, according to a grand jury indictment filed April 4 in U.S. District Court for the District of Massachusetts.
Children are considered lead exposed if blood tests show lead above a certain level. Some of the Magellan tests, including LeadCare Ultra and LeadCare II, included a flaw so they inaccurately showed low or no lead levels among children who potentially had lead levels above acceptable limits.
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