Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company […]

Source: Dark Daily - October 28, 2015 Category: Laboratory Medicine Authors: jude Tags: Coding, Billing, and Collections Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Labor Source Type: news