Devices

3 Former Magellan Execs Sentenced

A Massachusetts federal judge has sentenced three former Magellan Diagnostics executives for concealing a device malfunction that produced inaccurately low lead test results for thousands of children and other patients. A Department of Justice statement says the three pleaded guilty either to felony counts of introducing misbranded medical devices into interstate commerce or a felony count of making false statements.

The case involved Magellan’s LeadCare II and LeadCare Ultra devices that detected lead levels and lead poisoning in the blood of children and adults using either venous or fingerstick samples. The statement says the three misled Magellan customers and FDA about a serious malfunction that affected the LeadCare devices when they were used to test venous blood samples.

“By hiding the malfunction and later misleading customers and FDA about when they discovered the malfunction, the nature, extent, and frequency of the malfunction, as well as the risks associated with the malfunction, the defendants caused an estimated thousands of children and other patients to receive inaccurately low lead test results,” the department says.

The statement says FDA ultimately determined that the LeadCare devices could not accurately test venous samples, leading to a recall of all LeadCare devices using venous samples and a warning to the public not to use the devices for venous blood samples because of the malfunction.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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