FDA Recalls Ellume At-Home COVID Tests

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, indicating the test kits may produce “false positives” due to a 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. Earlier this year, the Biden administration cut a $231.8 million deal with Ellume to boost the availability of the tests in the U.S. market.

Ellume says it has corrected the manufacturing problem and the FDA says it is continuing to monitoring the company’s efforts.