Home COVID tests recalled over false positive results
(Gray News) – The Food and Drug Administration is recalling the Ellume COVID-19 Home Test over false positive results.
According to the FDA, certain lots of the test indicate that a person has the virus when they do not have it. Negative results do not appear to be affected by a 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 safety communication from the agency said.
A complete list of recalled Ellume COVID-19 Home Tests can be found on the company’s website.
If you purchased one of the recalled test kits, you can request a replacement by completing an online form.
Copyright 2021 Gray Media Group, Inc. All rights reserved.
