FDA warns of potential false positive results with certain lots of Ellume COVID-19 Home Tests

The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue.

The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved. A complete list of affected Ellume COVID-19 Home Tests can be found on Ellume’s website.

If you think you had a problem with the Ellume COVID-19 Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form. If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call (800) 638-2041 or (301) 796-7100.