False Positive Results with Certain Lots of Ellume COVID-19* Home Tests
U.S. Food and Drug Administration
WASHINGTON (News Release) - The FDA issued a safety communication to alert 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. A “false positive” is a test result that says a person has the virus when they do not actually have it. Negative test results do not appear to be affected by the manufacturing issue.
The FDA is not aware of any confirmed serious injuries or deaths related to the false positive results with the affected Ellume COVID-19* Home Tests at this time.
The FDA is working with Ellume to assess Ellume’s additional manufacturing checks and other corrective steps to address the reason for the manufacturing issue and help ensure that the issue is resolved.
This safety communication provides:
Recommendations for test users, caregivers, health care personnel, and the public who use the Ellume COVID-19* Home Test.
A summary of the FDA’s actions to address the issue.
Instructions for reporting problems with the Ellume COVID-19* Home Test to the FDA.
