Ellume’s COVID-19 Home Test Recall Most Serious, FDA Says

Ellume's COVID-19 home test units are seen at a digital diagnostics company in Australia, on Dec. 21. 2020. Patrick Hamilton/AFP via Getty Images

The U.S. Food and Drug Administration classified the recall of Ellume’s over-the-counter COVID-19 home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month.

Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall.