Aggregated News
Medical testing done by the closely watched start-up Theranos was plagued by quality control problems that could have led to inaccurate results for patients, according to an inspection report released by federal regulators on Thursday.
Among other findings in the report, which ran 121 pages, the company used unqualified or inadequately trained personnel and stored samples in freezers that were not at the proper temperature. It also failed to ensure that the quality control for an important blood-clotting test was acceptable before reporting results for patients.
The report is from an inspection last fall of Theranos’s laboratory in Newark, Calif., by the Centers for Medicare and Medicaid Services, which regulates clinical laboratories. Failure to correct the problems would put that laboratory in danger of losing its certification.
Brooke Buchanan, a spokeswoman for Theranos, said the company had revamped its procedures.
“We’ve made mistakes in the past,” she said in an emailed statement, “but when the company was made aware of the deficiencies we have dedicated every resource to remedy those failures.”
Privately-held Theranos has become known for...