The FDA issued a recall for over 2 million at-home COVID-19 tests developed by Australia-based Ellume USA LLC.
The Class I recall, the FDA’s most serious classification, was issued due to a concerning number of false positive test results.
More than 2 million at-home Covid-19 tests from Ellume have been recalled because of a number of false-positive results, the Food and Drug Administration said https://t.co/ijy8WqR91z
— The Wall Street Journal (@WSJ) November 11, 2021
More than 2 million at-home COVID-19 tests are being recalled due to a high number of false positive results. The U.S. Food and Drug Administration says it’s a Class 1 recall, the most urgent type, for the Ellume tests. https://t.co/t3AvQFaNPv
— Alaska's News Source (@AKNewsNow) November 12, 2021