Government: Theranos lab a danger to patient health
In another hurdle for one of Silicon Valley's high-flying startups, federal health inspectors are calling out blood-testing startup Theranos, saying practices at its Northern California laboratory "pose immediate jeopardy to patient health and safety."
The troubles, detailed in a Jan. 25 letter to the company, were uncovered during an inspection by the Centers for Medicare and Medicaid Services, the top federal overseer of clinical labs. If the problems aren't addressed, the lab in Newark, California, could be suspended from the Medicare program.
In an emailed statement on Wednesday, Theranos said it was working to fix the problems and would submit a "full plan of correction" to the federal agency within days.
The company stressed that none of the findings related to its Arizona lab, which it said processes over 90 percent of its tests.
In October, the Food and Drug Administration found the system Theranos used to authenticate its products to be defective.
CMS also found problems at the California lab during an inspection in late 2013.