... during an inspection by the Food and Drug Administration earlier this month, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board, according to the people familiar with the matter. 

Really, I know nothing about this world - but I do keep up with the news. A company that is run by a CEO who has been banned for two years from operating labs just weeks later is found out again. Cue - "Where Have All The Flowers Gone".

Maybe she should have stuck with Stanford.