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US FDA Tags Theranos Sample Tubes As Uncleared Devices

This article was originally published in Clinica

Executive Summary

The US FDA has stated that the Nanotainer blood specimen collection tubes made by embattled laboratory firm Theranos were being sold without proper 510(k) clearance and also cited the firm for a range of Quality System Regulation deficiencies in two FDA Form-483s posted online Oct. 27.

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