US FDA recalls 2.2 million Ellume COVID-19 home tests

Source: CBS News

“The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume due to ‘higher-than-acceptable false positive test results.’ Ellume, the first company to get FDA approval for over-the-counter COVID tests, had last month recalled 200,000 kits for the same issue. About 35 false positives through the Ellume COVID-19 Home Test were reported to the FDA, with no deaths reported, the agency said. But false positives could lead to negative outcomes such as getting unneeded COVID-19 treatment from a health care provider or a delayed diagnosis for the person’s actual illness, the FDA added.” (11/11/21)