Through a public records request, WSJ accessed the results of a Sept. 29, 2016 CMS inspection. Among the deficiencies listed, CMS found the company performed tests on improperly configured machines, staff did not verify if devices functioned with precision or accuracy, and Theranos did not properly inform all patients with potentially incorrect diabetes test results, according to the report.
WSJ first reported in January that Theranos did not disclose this failed inspection after it occurred in September. The publication did not have access to the details in CMS’ report at the time. Shortly after the inspection, the company decided to close the Arizona lab and shift focus away from blood testing and toward its miniLab testing device.
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