Millions of Ellume COVID-19 Home Tests Recalled Due to Excess False Positives

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.