FDA finds flaws in Theranos’ nanotainers and quality control procedures
The latest blow to Theranos’ blood testing technology comes from the US Food and Drug Administration, which found flaws in the company’s quality control procedures. In one of the two heavily redacted reports the FDA published, the agency says Theranos’ “design validation did not ensure the device conforms to defined user needs and intended uses.” The agency found out that Theranos describes its nanotainers (tiny containers for blood drawn by pricking a finger) as Class I medical devices, even though they fall under Class II, along with other higher-risk tools.
Via: The Verge
Source: The New York Times, Bloomberg, Financial Times, FDA (1), (2)
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