Theranos Inc., the once-hot medical unicorn startup,  just received a letter from the Centers for Medicare and Medicaid Services saying that its Newark, CA lab “pose[s} immediate jeopardy to patient health and safety”

Theranos has 10 days to comply or face the music

The letter sent, dated Jan. 25, by U.S government regulators was reported on Wednesday evening by multiple media outlets.

During an inspection by the federal government, Theranos’ violated no less that five laboratory regulations at its Newark, CA facility.

Speaking to blood testing specifically, the letter read, “It was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety.”

Beyond the physical threat in hematological areas the letter went on to speak of violations on three occasions from the lab’s staff as well as an issue with the company’s analytic systems.

Theranos is not unaccustomed to controversy following a series of pieces by the Wall Street Journal last year that questioned the core of the company’s business, its finger-prick blood testing technology.

This past Sunday, the Wall Street Journal once again turned its reporting to Theranos when it questioned practices at the Newark, CA lab prompting a response from the company.

“This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action.”

Following the letter sent this week, the company will have 10 days to show the agency that it is working to correct the problems detailed in the letter.

See the full letter here  Theranos_Inc_Cover_Letter_01-25-2016.0

THeranos

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