Theranos has withdrawn its application to the Food and Drug Administration for an emergency clearance of a new diagnostic blood test for Zika virus infections, according to the Wall Street Journal. The FDA’s emergency clearance process, used in times of extraordinary medical need, such as the current Zika outbreaks, is a lower regulatory hurdle than normal for new medical products.

The Zika test would have been carried out on Theranos' new MiniLab device; both were unveiled August 1 at a conference of the American Association for Clinical Chemistry. However, during a subsequent lab inspection, the FDA found that the company had collected some of the data on its Zika test prior to having patient-safety protocols in place. Theranos informed investors that it “recognized” the problem during the inspection and decided to withdraw its application.

The move is yet another stumble for the company, which appears to be trying to rebrand itself as a device manufacturer after federal regulators handed down heavy sanctions for safety issues in the company's clinical diagnostic work.

The startup biotech company gained notoriety and a hefty valuation—as high at $9 billion—with the promise of revolutionary technology that could run medical tests on just a few drops of blood from finger pricks that could bypass dreaded vein draws. But in July, the Centers for Medicare & Medicaid Services (CMS) revoked the company’s license to run one of its two clinical laboratories and banned its CEO and founder, Elizabeth Holmes, from owning, operating, or directing any lab for at least two years. The sanctions were levied after the CMS discovered several violations in its lab and test protocols, including one that posed “immediate jeopardy to patient health and safety.” Amid the painful sanctions, the company lost its largest commercial partner, Walgreens. It has also been sued by several ex-customers, it faces criminal charges for misleading investors and regulators, and it has seen seen its valuation drop to just $800 million.

Theranos announced last week that it is appealing the CMS sanctions. Appeals are rarely successful, though.

With the unveiling of the MiniLab at the start of the month, Theranos seemed to pivot its business model to selling diagnostic devices rather than running tests themselves. This may be the company’s only option if the sanctions hold.

At the AACC conference, Theranos billed the MiniLab as a convenient, automated device that combined standard lab equipment and tests in one unit to run a wide variety of medical tests on tiny volumes of blood with the push of a button. While not the revolutionary diagnostic technology the company made its name on, many scientists and experts at the AACC conference were generally impressed by the device’s design.

Still, some were skeptical of the company in general, given the past problems. And others expressed concern over the company’s rush to get clearance for a Zika test run on an untested diagnostic platform. They considered the move foolhardy and a repeat of past mistakes.

It appears that those critics were correct.