Ellume is recalling more than 2 million of its at-home COVID-19 tests after a higher-than-acceptable number of false positive results were reported to the FDA, the company said Nov. 10.
Ellume's at-home test is an antigen test that uses nasal samples and connects with a smartphone app to show users how to use the test and understand the results. The FDA granted it emergency use authorization in December for people ages 2 and older without a prescription. It's indicated for use in people with or without COVID-19 symptoms.
Ellume is recalling several lots of the test after 35 reports of false positives were sent to the FDA. False positives show that people have COVID-19 when they don't. A false positive diagnosis could lead to delayed treatment for the actual cause of a person's illness, receiving unnecessary COVID-19 treatment with drugs that could have negative side effects, and the falsely diagnosed person unnecessarily missing school or work, the FDA said.
The company is urging people who used a test from one of the affected lots within the last two weeks to get another test to confirm a positive result. Lot numbers can be found on the sticker on the side of the test carton. Affected tests that have been purchased but not used will be disabled via a software update. Ellume said it will also inform customers who used an affected lot and got a positive result.
Ellume said negative test results are reliable.
The FDA has classified the recall as Class I, the most serious type, meaning use could cause adverse health effects or death.
Read the full news release here.