Santa Clara, CA: Theranos, a company that developed a blood-test publicly available across the US, is facing legal action alleging consumer fraud in that it is endangering customer health through "massive failures" that misrepresented the accuracy and quality of its blood tests.
Allegations include false advertising and failing to follow proper lab procedures. Given that Theranos' claims that it had performed more than 6 million tests, thousands of consumers could be affected.
Reportedly, Theranos recently notified the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, nullifying some results and revising others. Theranos had advertised its Edison device as a ground-breaking technology able to test blood from just a pinprick.
CMS said in January that the blood-testing company's practices violated several clinical-laboratory regulations, jeopardizing patient health and safety. The Justice Department, the Securities and Exchange Commission, and the Centers for Medicare and Medicaid Services are investigating the company.
