The Food and Drug Administration is classifying the recall of the Ellume COVID-19 Home Test for giving false positive results as a Class I recall, the most serious type of recall. 

The agency said the “use of these tests may cause serious adverse health consequences or death.” The false positives could delay diagnosis or treatment for another serious non-COVID-19 illness, further spread the virus when presumed positive people are staying together or allow customers to access unnecessary COVID-19 treatment. 

The FDA also warned false positive results could lead people to avoid vaccination, if they think they already had the virus, or push them into isolation without cause.

Ellume began recalling certain lots of the test last month. The FDA added the classification Wednesday, saying Ellume had identified more defective lots since the agency's original alert, bringing the total number of affected tests to around two million. 

There have been 35 reports of false positive results and no deaths reported to the agency. The FDA said negative test results haven’t been affected.

Customers can find more information about identifying affected tests and what to do next via the FDA's information page. Affected tests that haven’t been used will be disabled through a software update, and Ellume will inform customers who used an affected test and got a positive result. 

WHY IT MATTERS

The Centers for Disease Control and Prevention reported the seven-day moving average of new COVID-19 cases as 73,312 as of Nov. 8, the most recent date available. Risk of community transmission is also high in most counties.

THE LARGER TREND

The FDA initially issued a warning about Ellume’s app-connected home tests giving false positive results in early October. 

The test originally received Emergency Use Authorization from the FDA in December, and the Biden administration inked a nearly $232 million deal with Ellume to increase the availability of its tests in the U.S. in February. 

ON THE RECORD

“While we cannot speak on behalf of the FDA, this is a follow-up to the agency’s announcement last month of Ellume’s voluntary recall in order to provide an update on the recall’s classification and additional lots impacted. 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.,” an Ellume spokesperson wrote to MobiHealthNews in an email.

“Importantly, not all of the positive results of the affected tests were false positives, and negative results were not affected by this issue. 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.”