The U.S. Food and Drug Administration announced the recall of 2.2 million home COVID-19 tests made by Ellume, the first company to get FDA approval for over-the-counter COVID tests, due to “higher-than-acceptable false positive test results.” The recall is an expansion of last month’s 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.
The FDA said that the reliability of negative test results aren’t impacted by the issue. But people who have bought an Ellume home COVID-19 test should check the product by entering the lot number at this Ellume website, which will determine whether the consumer has one of the impacted tests. The lot number is found on a sticker on the side of the product carton.
If a consumer received a positive test within the last two weeks by using one of the affected lots, they should contact their health care provider, the agency said.
The “incidence of false positives is limited to specific lots,” Ellume CEO Dr. Sean Parsons said in a statement. He also apologized to people who received false positives through the test kit “for any stress or difficulties they may have experienced.”