Ellume is recalling hundreds of thousands of at-home COVID-19 tests after multiple false-positive results.
A false-positive signals that a person is infected with the virus when they are not. Negative results do not appear to be affected by the manufacturing issue.
Test maker Ellume says it’s recalling dozens of lots. They shipped to retailers like Walmart, CVS, Target and Amazon between April and August of this year.
On October 5, 2021, the FDA alerted test users about the potential for false-positive results with certain lots of Ellume COVID-19 Home Test. The FDA says these lots have a recently identified manufacturing issue.
The FDA says it’s working closely with Ellume to help resolve the issue.
Contact your health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test if you received a positive test result with one of the affected lots of the Ellume COVID-19 Home Test in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result
Contact your health care provider, urgent care facility, or other COVID-19 testing site if:
You received a positive test result using one of the affected lots of the Ellume COVID-19 Home Test more than two weeks ago, and
You did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result
A health care provider can help you decide what next steps you should take
You should not assume that you had COVID-19 or have immunity to COVID-19
If you have an unused Ellume COVID-19 Home Test from an affected lot, use the Ellume COVID-19 Home Test App or follow the directions on Ellume’s websiteExternal Link Disclaimer to request a product replacement
The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people 2 years of age and older. The Ellume COVID-19 Home Test is for people with or without COVID-19 symptoms.