13th October 2021 Product update: rapidvirology staff writer
FDA-EUA Self-Administered COVID-19 Test is Recalled After False-Positive Reports
Ellume has issued a statement to say they have identified the reason behind the false positives returned by its COVID-19 self-administered antigen test but reassures consumers that the reliability of its negative results is unaffected.
The company says the issue is in the manufacturing process and limited to specific lots of the product.
Ellume's CEO Sean Parsons published an apology on the company's website:
"To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false-positive result."
In December 2020, Ellume's COVID-19 Home Test was the first over-the-counter test to be granted a EUA from the FDA. Soon after this authorization, the newly-elected U.S. president Joe Biden invested in rapid tests with Ellume signing a contract worth $231.8 million with the U.S. Department of Defense (DOD), in coordination with the Department of Health and Human Services (HHS), to accelerate domestic U.S. production of its COVID-19 home tests. Biden has recently announced another investment of several billion into rapid tests, as supply is struggling to meet demand.
Date Published: 13th October 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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