Australian manufacturer Ellume is recalling about 2 million at-home COVID-19 test kits over concerns about “higher than acceptable” false positives.
The company first initiated the recall in October for a few thousand kits, but this week it was expanded, the Food and Drug Administration (FDA) said Wednesday.
The agency identified the recall as Class I, or the most serious type, and said use of the tests “may cause serious adverse health consequences or death.”
The reliability of negative test results has not been impacted, the FDA and the company said.
The defective tests were manufactured by Ellume between Feb. 24 and Aug. 11 of this year. There have been 35 reports of false positive results sent to the FDA and no deaths reported.