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FDA Tags Theranos Sample Tubes As Uncleared Devices, Cites QSR Violations

This article was originally published in The Gray Sheet

Executive Summary

A prior media report of an FDA inspection of lab firm Theranos was confirmed with the agency's posting of two FDA Form-483s, citing the company for selling its Nanotainer blood specimen device without 510(k) clearance, and for Quality System violations. The closely watched firm says it has responded to FDA's observations and is transitioning from CLIA to Quality System Regulation compliance.

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