Ellume, a digital diagnostics company, is voluntarily recalling specific lots of the Ellume COVID-19 Home Test.
The company’s rapid, at-home COVID-19 test is an antigen test has been granted emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Ellume, with U.S. headquarters in Frederick, MD, said it is recalling certain lots of its tests “because there is an increased chance that tests from the affected lot numbers may give a false positive result.” The company decided to issue the recall after “specific product lots reported false-positive test result rates higher than was observed in clinical testing.”
Ellume said it has restarted distributing the COVID-19 Home Tests to retailers and distributors.
The affected Ellume COVID-19 Home Tests were distributed to retailers and distributors from April through August 2021.
