FDA recalling 2 million Ellume at-home COVID-19 test kits because of false positives

The U.S. Food and Drug Administration has announced a recall of about 2 million at-home COVID-19 test kits made by the Australian-based biotech company Ellume.

The federal regulatory agency says the test kits may produce "false positives" due to a manufacturing defect. The company first informed the FDA about the defect in some lots in October.

On Wednesday, the FDA said it had identified additional lots that have been affected by the manufacturing defect. The defective tests were manufactured by Ellume between Feb. 24, 2021 and Aug. 11, 2021. So far, 35 false positives from these tests have been reported to the FDA.

The FDA described the recall of the Ellume tests as "the most serious type," known as a Class I recall.