FDA Alert: 2 Million At-home COVID-19 Tests Recalled Over False Positives

Ellume's COVID-19 coronavirus home test units are seen at a digital diagnostics company in Australia, on Dec. 21. 2020. Patrick Hamilton/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) confirmed Thursday it is recalling some 2 million Ellume at-home COVID-19 testing because they can produce “false positives” due to a manufacturing defect.

The firm first informed the federal regulatory agency about the defect in some lots in October. But on Wednesday, the FDA said it identified additional lots that were affected by the manufacturing defect, made between Feb. 24, 2021, and Aug. 11, 2021.