Ellume, a digital diagnostics company, expanded its voluntary recall of specific lots of the Ellume COVID-19 Home Test, according to the U.S. Food and Drug Administration (FDA).
The original recall of the company’s rapid, at-home COVID-19 test was issued on October 6. The test is an antigen test that has been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
The recall was issued because of the potential for false positive results.
The affected Ellume COVID-19 Home Tests were distributed to retailers and distributors from February 24, 2021, to August 11, 2021.There are 2,212,335 tests involved.
