A documentary about Elizabeth Holmes premiered at the Telluride Film Festival in an unannounced screening, drawing attention back to a company whose central failure was not the one Holmes was convicted of. She was found guilty of defrauding investors. The people who received unreliable blood test results were never the subject of a criminal verdict.
You Can See Everything, directed by Nathan Fielder and Lance Oppenheim, runs 174 minutes and follows Holmes from 34 days before she entered federal prison across three subsequent years. A24 announced a theatrical release for October alongside the surprise screening. Holmes was convicted in January 2022 on four counts of defrauding investors and sentenced that November to more than 11 years.
The distinction between investor fraud and patient harm is the part where most coverage collapses, and it is the part that matters for anyone who has a blood test drawn.
The Numbers Behind the Patient Side
Theranos voided or corrected tens of thousands of blood test results. Its own laboratory director later testified that he voided every test run on the company's proprietary Edison devices across 2014 and 2015, telling Holmes the instruments had never performed properly.
Arizona produced the clearest accounting because the state attorney general pursued it. Between 2013 and 2016, Theranos sold roughly 1.5 million blood tests to more than 175,000 Arizona residents through a partnership with Walgreens. About 10.5 percent of those tests were voided or corrected. The company agreed to pay 4.65 million dollars to refund every Arizona customer, plus 200,000 dollars in civil penalties and 25,000 dollars in legal fees, and the refund applied whether or not a person's results had been voided or corrected. Theranos admitted no wrongdoing and denied misrepresenting the accuracy of its technology.
Federal inspectors reached the company's California laboratory first. A survey completed in November 2015 found conditions that the Centers for Medicare and Medicaid Services described in a January 2016 letter as posing immediate jeopardy to patient health and safety, citing deficiencies across five CLIA conditions. A released inspection report documented quality control checks on the Edison device that fell outside the company's own standards, tests run by unqualified personnel, and failures to notify patients and physicians when results were flawed. A later federal inspection of the Arizona laboratory found similar notification failures involving diabetes related testing and improperly configured blood coagulation testing.
The federal penalty for all of this was a civil monetary penalty of 30,000 dollars, reached in a settlement under which the agency withdrew its revocation of the company's laboratory certificate in exchange for Theranos dropping its appeals and agreeing not to own or operate a laboratory for two years.
The Regulatory Question That Is Still Open
Theranos operated as a clinical laboratory offering tests it developed itself. Those are known as laboratory-developed tests, and they have historically been overseen by CMS under the Clinical Laboratory Improvement Amendments rather than reviewed by the Food and Drug Administration before use.
CLIA inspects laboratories for process and quality control. It does not require a laboratory to demonstrate that a test it invented actually measures what it claims to measure before that test is used on patients. That gap is the mechanism by which unvalidated tests can reach real people, and it was not a Theranos invention.
The FDA attempted to close it. A rule published in May 2024 would have treated these tests as medical devices subject to agency oversight, phased in over four years. A federal court in the Eastern District of Texas vacated that rule in its entirety on March 31, 2025, holding that the agency lacks statutory authority because such tests are professional services rather than manufactured devices. A Congressional Research Service summary of the ruling notes the court remanded the matter to the FDA.
The agency did not appeal. In September 2025, it formally rescinded the rule through a final rule restoring the earlier regulatory text. Oversight now sits where it sat before Theranos, with CMS under CLIA.
Competing Views on Whether That Is a Problem
This is a genuine dispute among people with expertise, and it should not be flattened. Laboratory organizations and pathology groups argued the vacated rule would have imposed high costs, slowed development of tests for rare conditions, and duplicated oversight that CLIA already provides. In its statement after the ruling, the American Clinical Laboratory Association argued the decision protects patient access to needed testing services.
Patient safety advocates and the FDA argued that CLIA verifies laboratory processes without verifying that individual tests are accurate, and that the volume and complexity of modern tests, particularly genetic and cancer-related ones, have outgrown a framework written in 1988.
The court decided the legal question of agency authority. It did not decide whether the oversight gap is a public health problem. Closing it now would require Congress, and no legislation has passed.
Reasonable Steps for Patients Getting Blood Work
Most laboratory testing in the United States is reliable, and this is not a reason to avoid blood work a clinician orders. The practical exposure for an individual is narrower than the history suggests.
Where it matters is direct-to-consumer testing, where a person orders a test without a clinician involved. Asking whether a test has been reviewed by the FDA or is offered as a laboratory-developed test is a fair question, and a company that cannot answer clearly is telling you something. Results that would change a major decision are worth confirming through a second laboratory before acting.
For any unexpected result, the most useful step is the least dramatic one. Ask the ordering clinician whether the finding fits the clinical picture and whether repeating the test is warranted. Laboratory error is uncommon but not rare, and a result that contradicts everything else about a patient's situation deserves a second look regardless of which laboratory produced it.
The documentary reaches theaters in October. The regulatory question it circles has been open since 1988 and remains open now.
Key Questions Answered
What was Elizabeth Holmes actually convicted of? Four counts of defrauding investors, in January 2022. She was not convicted of charges relating to patients who received inaccurate test results.
How many patients were affected? Theranos voided or corrected tens of thousands of results. In Arizona alone, about 10.5 percent of roughly 1.5 million tests sold to more than 175,000 residents were voided or corrected.
What penalties did the company face for the laboratory failures? A civil monetary penalty of 30,000 dollars from CMS, and a 4.65 million settlement with the Arizona Attorney General refunding customers.
What is a laboratory developed test? A test a clinical laboratory designs and runs itself. These have been overseen by CMS under CLIA rather than reviewed by the FDA before use.
Did regulators close the oversight gap after Theranos? No. An FDA rule to regulate these tests was vacated by a federal court in March 2025 and formally rescinded by the agency that September.
Is routine blood work safe? Most United States laboratory testing is reliable, and this history is not a reason to skip tests a clinician orders.
What should someone do about an unexpected result? Ask the ordering clinician whether it fits the clinical picture and whether repeating the test is warranted, particularly before making a major decision.
