WASHINGTON — Diagnostic company Ellume has issued a voluntary recall for specific lots of its at-home COVID-19 tests, due to an increased chance the results could be a false positive.
Ellume is one of several companies who have received Emergency Use Authorization by the U.S. Food and Drug Administration for rapid antigen COVID-19 tests.
The company's CEO said they were able to confirm the increased chance of false positives was isolated to specific lots.
"In recent weeks, we noted an increased chance that Ellume COVID-19 Home Tests from specific product lots may provide an incorrect positive result," Ellume CEO Dr. Sean Parsons said in a statement. "Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots."
Parsons added that they determined the reliability of negative results was not impacted by the issue.
Only Ellume COVID-19 tests from specific lots listed on the company's website have been recalled. Those tests were distributed to retailers and distributors from April to August 2021. Consumers who try to use an affected test will be notified in the Ellume COVID-19 Home Test app that the test has been recalled and disabled.
The company did not immediately respond to a request for comment on how many total tests were recalled.
If you've already used the test and want to see if it was affected, you can check online here by submitting your zip code and analyzer ID #.
Customers who have purchased one of the recalled test kits can request a replacement by filling out a form on the company's website.
According to the company's announcement, some of the tests included in the recall were distributed by the Department of Defense. Earlier this year, the DOD awarded the Ellume a $238.1 million contract to increase production of its at-home tests in the United States.