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November 12, 2021

Health Law Weekly

Two Million Ellume At-Home COVID-19 Tests Recalled on False Positives

  • November 12, 2021

Ellume Ltd is recalling more than two million COVID-19 at-home tests it manufactures because of a higher-than-acceptable risk of false positives, the Food and Drug Administration (FDA) said November 10. 

The Class I recall, which is the most serious, affects tests distributed between April 13 and August 26, the agency noted on its website.

The FDA has received 35 reports of false positives with the tests, which the agency said could lead to unnecessary treatment, unnecessary quarantine, and delays in diagnosis of other conditions. The reliability of negative test results is not affected, the agency said. 


  • Coronavirus Pandemic