The Food and Drug Administration is warning that certain lots of the Ellume COVID-19 Home Test may be giving false positive results due to a manufacturing issue.

The agency said negative results don’t appear to be affected, and that it’s working with the company to assess its manufacturing checks and take steps to fix the error.

Ellume is asking customers to check if their tests are part of the affected lots using this webpage. The affected tests were distributed to retailers and other distributors from April through August 2021. 

Ellume said it will directly email customers who had used an affected test and tested positive in the last 14 days. Those who attempt to use the affected tests will be alerted in Ellume’s app.

The FDA advises users who received a positive result from an affected Ellume test in the last two weeks to receive a COVID-19 molecular diagnostic test. Customers should contact a healthcare provider for next steps if they received a positive test result more than two weeks ago, or if they didn’t receive a positive result from a different COVID test at the time of the original Ellume positive result.

WHY IT MATTERS

COVID-19 cases are currently trending downward, but the U.S. recorded more than 28,800 new cases on Oct. 3, the most recent date available, according to the Centers for Disease Control and Prevention’s COVID Data Tracker.

THE LARGER TREND

Ellume’s app-connected home test was first approved for Emergency Use Authorization by the FDA in December. 

In February, the Biden administration inked a $232 million deal with Ellume to increase the availability of its tests in the U.S.

ON THE RECORD

“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,” Ellume CEO and founder Dr. Sean Parsons said in a statement.

“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.”