Key Takeaways

Ellume has recalled over 2 million of its at-home COVID-19 test kits since October.

A manufacturing error resulted in higher-than-expected false-positive test results.

The FDA classified the recall as Class I, the most serious type of recall, and warned customers about serious adverse effects.

Ellume recalled around 195,000 of its at-home COVID-19 tests in October because of a manufacturing error that resulted in too many false-positive results. The Australian company has since identified more than 2 million affected tests in the United States.

The Food and Drug Administration (FDA) today classifiedthe recall of Ellume’s COVID-19 Home Test as Class I, the most serious type of recall. The agency warned that the “use of these tests may cause serious adverse health conseq

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