Theranos, the life sciences company that claimed their blood testing device was revolutionary, have corrected, voided and revised tens of thousands of blood test results issued in 2014 and 2015, according to the Wall Street Journal.
Physician practices in Phoenix recently started receiving corrected tests from Theranos, while the drugstore Wallgreens Boots Alliance was informed about the corrected results.
The remarkable move from Theranos to void and revise results follows an inspection by the Centers for Medicare and Medicaid Services (CMS) that highlighted failings in the labs accuracy. The ramifications of the inspection left the company facing a possible criminal investigation for potentially misleading investors and hefty fines, while founder, Elizabeth Holmes, may be banned from the blood-testing industry for a period.
With the company’s records showing that their lab in California ran about 890,000 tests a year, the potential number of patients affected by erroneous test results could be great. According to the source, the ‘Edison’ device — which Theranos claimed could run multiple tests from just a few drops of fingertip blood — was actually only used for 12 out of more than 200 tests offered to consumers. Seemingly, the majority of tests were done using traditional machines. In June 2015, tests done with the ‘Edison’ were completely stopped.
Brooke Buchanan, a spokesperson for Theranos 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.”
The final decision by the CMS on any sanctions for Theranos is expected to come soon. They could include a revoking of the lab’s federal license and fines. In addition, a verdict on the potential banning of founder Elizabeth Holms from the industry for a period is expected to be decided upon.
Reports have also emerged that suggest Theranos’ Arizona lab performed blood tests using a traditional machine from Siemens using incorrect settings. In response, Siemens issued a statement which read, “when maintained and used properly, our equipment and tests will perform to specifications and deliver fast, accurate and reliable results to our customers.”