FDA recalls 2.2 million Ellume COVID-19 home tests due to false positives
CBSN
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.
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.
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