FDA Recalls Millions of Ellume At-Home COVID-19 Tests After Reports of False-Positive Results

The Food and Drug Administration (FDA) has issued a recall of millions of at-home COVID-19 tests after reports of false-positive results.

More than 2.2 million at-home Rona tests, created by digital diagnostics firm Ellume, had to be recalled this week after the FDA received 35 reports of false-positive test results. Fox Business reports the recall had to be classified as a “class 1” recall, which is the most severe type of recall because of the possibility of “serious adverse health consequences or death.”

The test involves a less invasive nasal swab than the ones health provides use; the test sees proteins from the SARS-CoV-2, the news outlet reports. The recall comes after the company found a “manufacturing issue” last month.

The FDA said the false-negative results people receive from the tests are reliable as they were not affected by the manufacturing issue. “Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” a spokesperson for the company told FOX Business on Thursday. They mentioned that the malfunction had been fixed.

“The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false-positive result. We have and will continue to work diligently to ensure test accuracy, in all cases,” they continued.