WASHINGTON — Editor's Note: The video above is from the FDA's first warning of false positives with Ellume COVID tests in October.
Ellume is recalling more than 2 million at-home COVID-19 test kits over concerns of high rates of false positives, the U.S. Food and Drug Administration announced Wednesday. A false positive is when the test tells people they have the virus when they in fact do not. The FDA says however that the test's reliability of negative test results has not been affected.
The FDA gave the Ellume test kits an Emergency Use Authorization in December 2020.
This isn't the first time the FDA has warned about increased false positives with this product. In October, Ellume recalled other lots of tests over the same reason. At that time, Ellume CEO Dr. Sean Parsons said in a statement said: "Following a thorough investigation, we isolated the cause and confirmed that this incidence of false positives is limited to specific lots."
Wednesday's recall affects tests distributed between April 13, and Aug. 26, 2021. In order to check if one of these tests is in your home, Ellume recommends checking the lot number on the packaging. From there, customers can cross reference the lot number with the FDA's Medical Device Recall Database Entry. If the test is included on the list, you can visit Ellume's return website or contact the company at email@example.com
According to the FDA, false positives could lead to things like delays in treatments for other serious conditions; spreading of COVID, when people who are presumed to have the virus in fact do not; receiving unnecessary COVID treatment, and more.