FDA recalls 2.2 million at-home coronavirus tests due to false positives

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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. 

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The manufacturing process for Ellume’s at-home COVID-19 tests. 

A spokesperson for Ellume said Thursday that the company has already corrected the manufacturing issue. 

"Ellume has investigated the issue, identified the root cause, implemented additional controls, and we are already producing and shipping new product to the U.S.," the spokesperson told FOX Business. 

"The Ellume team offers its sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases."

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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. 

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Ellum’s manufacturing facility in Frederick, Maryland. 

Ellume originally announced last month that 427,000 tests needed to be recalled due to a "recently identified manufacturing issue." That number had expanded to 2,212,335 this week. 

A company spokesperson said Thursday that about 660,000 of those test kits have already been used, resulting in 118,000 positive tests, which include both true and positive tests. 

Ellume CEO Dr. Sean Parsons apologized to consumers and noted that negative test results are not affected.

"At Ellume, we understand that trust is central to fulfilling our purpose as a company, and we recognize that this incident may have shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic," the CEO said in a statement. 

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

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The FDA noted the potential for adverse results from a false positive, such as a delayed diagnosis for the actual cause of a person's illness, spread of COVID-19 when someone who has a false positive is grouped with other positive people, and the potential for unnecessary COVID-19 treatments that could have side effects. 

While the company is taking affected kits off store shelves, they are advising consumers to visit www.ellumecovidtest.com/return to see if a product they used is part of the affected lots. 

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