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