(Reuters) - The U.S. Food and Drug Administration said privately held laboratory operator Theranos had been shipping a blood testing device under a wrong classification that exempted the product from regulatory control.
The device in question is the company’s Capillary Tube Nanotainer (CTN), a tiny vial used to collect blood from patients.
The regulator said on Tuesday that Theranos was shipping the device under its low-risk “Class I” category, which includes products such as dental floss, when it should have been classified under a higher risk “Class II” category.
Medical devices that come under FDA’s Class I category are deemed low risk and are subject to little or no regulatory control.
The FDA said the “uncleared medical device” was shipped across California, Arizona and Pennsylvania.
The regulator also noted quality audits had not been performed at Theranos's Newark, California facility. (1.usa.gov/1MpBrra)
Theranos has been in the spotlight after the Wall Street Journal published a couple of stories suggesting the blood-testing startup was relying on traditional lab tools as it struggles with its own technology.
The startup, which has a valuation of $9 billion, is promising to shake up medical testing by conducting a wide range of tests with one drop of blood from a finger-stick using its Nanotainers, rather than the large vial typically collected.
So far, the healthcare startup has FDA clearance to sell blood tests for the sexually transmitted herpes simplex virus, and expects to get clearance for others.
The company, which was not immediately available for comment, has the option of discussing either its objection to the regulator’s observations or corrective actions with representatives.
Reporting by Natalie Grover and Vidya L Nathan in Bengaluru; Editing by Savio D'Souza, Saumyadeb Chakrabarty and Anil D'Silva