www.fdanews.com/articles/205318-millions-of-ellume-covid-19-home-tests-recalled-due-to-excess-false-positives
Millions of Ellume COVID-19 Home Tests Recalled Due to Excess False Positives
November 12, 2021
The FDA has issued an update on Ellume’s recall of its COVID-19 Home Tests, deeming it a Class I recall because of the risk of serious injury or death.
The FDA has granted its Emergency Use Authorization to the rapid, at-home COVID-19 antigen test developed by the Frederick, Md.- and Brisbane, Australia-based company.
The reason for the recall of certain lots of the test, totaling more than 2.2 million individual tests in all, is that they have a higher-than-acceptable rate of false-positive test results. The affected diagnostics were manufactured between Feb. 24 and Aug. 11, and distributed between April 13 and Aug. 26.
There have been 35 reports of false-positive results sent to the FDA but no deaths reported, the agency adds.