Digital diagnostics company Ellume is recalling its at-home COVID antigen tests because they may produce false-positive results in rates higher than was observed in clinical testing.

The company said it was investigating the issue and implementing additional control measures, saying that it was “continuing to work on resolving the issue that led to this recall.”

The at-home COVID test was granted emergency use authorization from the Food and Drug Administration and affects tests that were distributed in the U.S. and Australia from April to August.

A full list of lot numbers can be viewed here.

Ellume said it is providing replacements of the COVID at-home tests. Consumers can find instructions for a replacement test kit at www.ellumecovidtest.com/return.

All affected tests will be removed from store shelves and consumers who still try to attempt to use the affected tests will be notified in the Ellume COVID-19 Home Test app that the test has been recalled and disabled. They will then be directed to www.wllumecovidtest.com/return to request a test kit replacement.

Consumers that used a recalled test and tested positive in the last 14 days will be notified directly by email about the recall. Consumers who did not test positive should immediately obtain a new test and assume they have COVID-19, Ellume said. They should also self-isolate and take necessary precautions, the company warned.

Ellume also said that consumers who did not have a positive test before Sept. 17 may have had incorrect test results. They may not assume they are immune to COVID and should take precautions to avoid COVID infections, including vaccinations per the Centers for Disease Control and Prevention guidelines.

Questions about the recall can be directed to the Ellume Product Support Team at 1-888-807-1501, Monday through Friday, from 9 a.m. to 5 p.m. ET, to arrange a replacement test kit.

Adverse events or product complaints can be reported to the Ellume Customer Support Team at 1-888-885-6121, Monday through Friday, from 9 a.m. to 9 p.m. ET, and Saturday and Sunday from 10 a.m. to 6 p.m. ET.

In a statement, Ellume CEO Dr. Sean Parsons said, “At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic. To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result.”

Australian company Ellume is producing a Covid test kit that delivers results in just 15 minutes Australian company Ellume is producing a Covid test kit that delivers results in just 15 minutes Photo: AFP / Patrick HAMILTON