Posted by Michael Wonder on 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA 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.
