The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious type of recall, for over 2 million Ellume COVID-19 home tests after 35 reports of false positive results sent to the FDA.
The recalled Ellume COVID-19 Home Test was manufactured February 24, 2021 to August 11, 2021 and was distributed April 13, 2021 to August 26, 2021.
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 two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms. This at-home test uses swab samples taken from further up inside the nose (mid-turbinate) but not as deep inside the nose to reach the back of the throat (nasopharyngeal) where a health care professional collects a sample. The Ellume COVID-19 Home Test uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the test results.
The FDA issued an Emergency Use Authorization (EUA) on December 15, 2020 and authorized a revision to the EUA on February 11, 2021 to allow emergency use of the Ellume COVID-19 Home Test.