More than two million at-home COVID-19 tests are being recalled due to high false positive results.
The U.S. Food and Drug Administration issued a Class I recall, the most urgent type, for Ellume, the brand responsible for the false positives.
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Regulators said false positives could lead to a delayed diagnosis or treatment of the actual cause of a person’s illness.
There have been 35 reports of false positives. No deaths have been reported.
The FDA said the reliability of negative test results is not affected.
The tests were manufactured between Feb. 24 and Aug. 11 and were distributed from Apr. 13 to Aug. 26.
Those who have received a positive result with an Ellume test are advised to have a follow-up test.
The Biden administration in February awarded nearly $232 million to Ellume to produce its at-home tests.
And this fall, the administration announced billions more dollars to help make more tests available.