Theranos founder and CEO Elizabeth Holmes speaking in San Francisco last year.
The Edison machines were touted as revolutionary and were the main basis for the $9 billion valuation attained by the Palo Alto, Calif., company in a funding round in 2014.
The company has told the Centers for Medicare and Medicaid Services that it has issued tens of thousands of corrected blood-test reports to doctors and patients, voiding some results and revising others, according to the person familiar with the matter.
In response to questions from The Wall Street Journal about the blood-test corrections, Theranos spokeswoman Brooke Buchanan said: Excellence in quality and patient safety is our top priority and we ve taken comprehensive corrective measures to address the issues CMS raised in their observations.
As these matters are currently under review, we have no further comment at this time.
CMS also has threatened to revoke the California lab s federal license and impose fines against Theranos.