Amy Winslow, former CEO, pleaded guilty to one felony count for introducing misbranded medical devices into interstate commerce. Hossein Maleknia, former COO, pleaded guilty to two felony counts of the same charge, and Reba Daoust, former director of quality assurance and regulatory affairs, pleaded guilty to one felony count for making false statements, according to a March 11 news release from the Department of Justice.
The defendants had misled customers and the FDA about a malfunction in Magellan’s LeadCare devices when testing venous blood samples, leading to thousands of inaccurate lead test results.
The faulty tests, which were conducted between 2013 and 2017, may have put children and other vulnerable patients at risk of undetected lead exposure, the release said.
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