The U.S. Food and Drug Administration has announced a recall of over 2 million at-home COVID-19 tests from the Australian medical technology company Ellume due to potential false positives.

The FDA’s recall is a Class I, meaning it is “the most serious” of the types of recalls. The FDA warned that “Use of these tests may cause serious adverse health consequences or death.”

“The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older. The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms,” the FDA explained, adding, “The FDA issued an Emergency Use Authorization (EUA) on December 15, 2020 and authorized a revision to the EUA on February 11, 2021 to allow emergency use of the Ellume COVID-19 Home Test.”

“The company first informed the FDA about the defect in some lots in October,” NPR reported. “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.”

As reported by CNN, “In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.”
A spokesperson for Ellume told The New York Times that the cause of the defects has now been identified.

“Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.,” the spokesperson said. “Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue.”