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https://www.fox5ny.com/news/fda-recalls-2-2-million-at-home-coronavirus-tests-due-to-false-positives
FDA recalls 2.2 million at-home coronavirus tests due to false positives
By Paul Best
Published November 11, 2021 8:55PM
News
FOX Business
WASHINGTON - The FDA announced this week that the recall of more than 2.2 million at-home COVID-19 tests by digital diagnostics firm Ellume is being classified as a class 1 recall, which is the most serious type due to the potential for "serious adverse health consequences or death."
Ellume's at-home test detects proteins from the SARS-CoV-2 virus through a less invasive nasal swab than the one that health providers normally use.
The recall is due to a "manufacturing issue" that was first identified by the company last month and could lead to a false-positive result.
The FDA said Wednesday that it has received 35 reports of false-positive test results, but noted that negative test results are still reliable and not affected by the manufacturing issue.
...
Ellume's diagnostic test was granted emergency use authorization last December, making it the first fully at-home over-the-counter COVID-19 test in the United States.
The Biden administration struck a $230 million deal with Ellume in February and the company announced in May that it was building a manufacturing facility in Frederick, Maryland that will be able to produce 19 million tests a month when fully operational...
FDA recalls 2.2 million at-home coronavirus tests due to false positives
By Paul Best
Published November 11, 2021 8:55PM
News
FOX Business
WASHINGTON - The FDA announced this week that the recall of more than 2.2 million at-home COVID-19 tests by digital diagnostics firm Ellume is being classified as a class 1 recall, which is the most serious type due to the potential for "serious adverse health consequences or death."
Ellume's at-home test detects proteins from the SARS-CoV-2 virus through a less invasive nasal swab than the one that health providers normally use.
The recall is due to a "manufacturing issue" that was first identified by the company last month and could lead to a false-positive result.
The FDA said Wednesday that it has received 35 reports of false-positive test results, but noted that negative test results are still reliable and not affected by the manufacturing issue.
...
Ellume's diagnostic test was granted emergency use authorization last December, making it the first fully at-home over-the-counter COVID-19 test in the United States.
The Biden administration struck a $230 million deal with Ellume in February and the company announced in May that it was building a manufacturing facility in Frederick, Maryland that will be able to produce 19 million tests a month when fully operational...