Theranos' Arizona lab did not ensure that patients who might have received incorrect diabetes test results were informed, the Wall Street Journal reports. In addition, according to a federal inspection report the paper obtained, the lab performed blood coagulation testing using a machine that was not set up properly.
"The findings show that Theranos repeatedly violated its own policies and procedures, as well as a manufacturer's instructions for using lab-testing equipment," the Journal writes.
The firm shut its Arizona lab down in October as it began its pivot from a blood-testing company to a technology development one. A previous federal inspection uncovered "condition-level deficiencies" at Theranos' California lab led to regulators proposing sanctions against the firm, including barring CEO Elizabeth Holmes from owning or running a clinical lab. The firm shuttered the California lab over the summer.
This latest inspection took place in September, shortly before the Arizona lab closed. According to the Journal, inspectors found that the firm didn't verify that the testing platforms' precision or accuracy met manufacturers' guidelines — the lab used conventional testing devices, not Theranos' Edison platform. This affected a number of tests, including one gauging blood-glucose, prostate-specific antigen, and triglyceride levels, it adds.
The Journal notes that Theranos has acknowledged the deficiencies and is working to resolve the situation.