FDA investigates Theranos System blood testing devices and procedures

A report and FDA inspections have shown that Theranos System violated FDA regulations for its testing devices. The company was allegedly using a non-validated capillary tube nanotainer blood collection device and risk and hazard analyses were not documented. There was no set procedure for dealing with customer complaints. FDA inspections revealed quality control issues. The Wall Street Journal has published articles questioning the company's proprietary technology and the company has not published data on its tests in peer reviewed journals. The company hopes to disclose data on the accuracy and reliability of its tests. Most of Theranos’s tests are offered through Walgreens drugstores in Arizona.

Comment: The company secured FDA 510(k) approval for its patented finger stick test for herpes simplex virus i IgG in July 2015.