Alere to Pay $39 Million in Diagnostic Device Fraud Settlement

Alere Inc. and Alere San Diego Inc. will pay nearly $39 million to resolve allegations that they violated the False Claims Act by billing Medicare for defective rapid point-of-care testing devices, the U.S. Attorney’s Office for the District of New Jersey said Thursday.

The device manufacturers allegedly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries between 2008 and 2016, the government’s announcement said.

Alere allegedly knew since 2008 that a software algorithm used in the monitors had a material defect that produced inaccurate and unreliable results for some patients, the announcement aid.

Despite awareness that the devices ...