Ellume recalling more than 2 million at-home COVID-19 test kits

FDA, Ellume recalling more than 2 million at-home COVID-19 test kits Australian manufacturer Ellume is recalling about 2 million at-home COVID-19 test kits over concerns about "higher than acceptable" false positives. Nathaniel Weixel TheHill

Australian manufacturer Ellume is recalling about 2 million at-home COVID-19 test kits over concerns about "higher than acceptable" false positives.

The company first initiated the recall in October for a few thousand kits, but this week it was expanded, the Food and Drug Administration (FDA) said Wednesday.

The agency identified the recall as Class I, or the most serious type, and said use of the tests "may cause serious adverse health consequences or death."

ALSO SEE: FDA statement: Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results