FDA Probes Fraud Claims Against Blood-Test Maker Theranos Corp.

Dec 21, 2015

Former employees of blood-test maker Theranos alerted the FDA, Medicaid, and Medicare agencies this year that the company has been falsifying product-testing results. 

Complaints about Thernanos manufacturing defective pin-prick kits, and rigging its laboratory control experiments in order to disguise their inefficacy, began emerging in September 2015.

This month, however, the Food and Drug Administration received troubling proof from an ex worker that research for one of its popular herpes-testing devices deviated from “proper protocols.”

The whistleblower also disclosed that, during the required patient-tests for that particular product, several of its “failing” parts were secretly modified to pass the FDA’s stringent criteria.

Federal regulators there have confirmed this week that, in the interest of public safety, they’re now actively investigating Theranos’ various blood-testing devices for “major stability, precision, and accuracy” issues.

If these do indeed prove defective -- and company heads conspired to fabricate favorable test results proving otherwise -- that level of corporate malfeasance could lead to both civil and criminal penalties.

Criminal Fraud



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