On May 20, Massachusetts-based Magellan Diagnostics agreed to pay $42 million and pleaded guilty to charges related to the concealment of a device malfunction.
Magellan, a Meridian Bioscience business, admitted to misleading customers and the FDA about a serious malfunction in its LeadCare devices, which test venous blood samples. The devices produced false, low lead test results for up to tens of thousands of children, the Justice Department said in a news release.
The company said it knew about the malfunction before the product's release in 2013, but Magellan told the FDA it first discovered the issue in late 2014 after receiving customer complaints. The manufacturer warned customers about the problem in 2016, and a recall of all LeadCare devices using venous samples soon followed.
Between 2013 and 2017, "LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted" in the U.S., the release said.
Meridian said the malfunction was remediated in 2018, adding that all current Magellan devices and tests are "safe, FDA-cleared and are performing as intended."
To resolve criminal charges, the manufacturer will pay a $21.8 million fine, another $10.9 million in forfeiture and at least $9.3 million to compensate patient victims, according to the Justice Department.