Already facing criticism that its technology was not living up to its billing, blood-testing startup Theranos is getting additional unwanted attention -- this time, from the U.S. government.
The system used by Theranos to authenticate its products is defective, according to the Food and Drug Administration, which on Tuesday posted heavily redacted reports on its site.
The agency said the company's "design validation did not ensure the device conforms to defined user needs and intended uses." The name of the device was blacked out. Theranos is best known for a device that can test blood samples without using traditional needles.
The FDA inspections were conducted Aug. 25 through Sept. 16 at the company's offices in Palo Alto and Newark, California.
The company, which has a valuation of $9 billion and an all-star board of directors, has said its technology can use finger-prick samples for tests that had required entire vials of blood.
Theranos said it is working with the FDA to allay any concerns. "We believe that we addressed and corrected all the observations at the time of, or within a week of, the inspection and have submitted documents to FDA that say so," the company said in an emailed statement.
The FDA documents said the company's blood-collecting invention, which Theranos calls a capillary tube nanotainer, is a Class II medical device, which is viewed as riskier than the Class I that Theranos categorizes it under.
"You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona and Pennsylvania," the regulator reported.
The FDA's observations came in a form 483, which the agency issues if it finds federal manufacturing guidelines have been violated.
for more features.