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Theranos Vial “Uncleared Medical Device”

The U.S. Food and Drug Administration today declared Theranos Inc.’s tiny vials (called nanotainers) used for collecting finger pricked blood from patients an “uncleared medical device.” The FDA investigation which began on August 25 found a number of problems with the quality assurance process utilized by Theranos. Evidently, according to reports, Theranos did not meet with suppliers to determine if their products met the Theranos own specifications.