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FDA Inspection Report Cites Theranos Used “Uncleared Medical Device”

October 27, 2015
by Heather Landi
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The U.S. Food and Drug Administration found flaws in the process that medical testing company Theranos used to validate its blood-testing products, according to inspections reports the agency posted to its website.

The FDA has posted two inspection reports to its website based on inspections conducted August 25th through September 16th at Theranos’ Palo Alto, Calif. and Newark, N.J. facilities.

Healthcare Informatics obtained access to the FDA inspection reports from a link in an online article posted by Bloomberg Business.

Theranos is a biomedical startup that has developed technology for a blood testing device that requires only a finger prick blood sample for lab tests, as opposed to patients’ getting their blood drawn via a needle in a doctor’s office or lab, which often requires vials of blood.

One inspection report, which is heavily redacted, states that the “design validation did not ensure the device conforms to defined user needs and intended uses” and that the “design was not validated under actual or simulated use conditions.”

In a second inspection report for Theranos, Inc., the FDA states that the company’s “capillary tube nanotainer (CTN), a blood specimen collection device,” which refers to the small vials the company uses for the finger stick blood sample, is a “Class II medical device,” yet Theranos listed the device as a “Class I exempt medical device.”

The inspection report states, “You are currently shipping this uncleared medical device in interstate commerce, between California, Arizona and Pennsylvania.”

According to the Bloomberg Business article, the company said it had “addressed and corrected all the observations at the time of, or within a week of, the inspection.”

While Theranos lists about 200 tests on its online menu, the company said this month that it is using its new technology on only one test.

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