Ellume has recalled more than 2.2 million COVID-19 Home Test kits due to a high rate of false positives.

The recalled tests were manufactured between April 13 and August 26 and sold throughout the U.S.

The rapid at-home antigen tests use nasal swabs to check for proteins from the SARS-CoV-2 virus, which causes COVID-19.

The FDA said no deaths were reported, but false positives could lead to a person receiving unnecessary COVID-19 treatment, or a delayed diagnosis and treatment of an actual illness.

The recall is an expansion of an earlier recall Ellume issued in October for 200,000 at-home test kits due to the same issue. According to the recall, around 35 false positives were reported with the test.

Anyone who may have received a positive test from the recalled kits should contact their health care provider, urgent care facility, or other COVID-19 testing site and ask for a COVID-19 molecular diagnostic test to confirm the positive test result.

Ellume Recalls 2 Million At-Home COVID-19 Test Kits

Source: Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results

Posted by Daily Hornet

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