Ellume, the first business to get FDA certification for over-the-counter COVID testing, has recalled 2.2 million home COVID-19 test kits, according to the US Food and Drug Administration.
High False-Positive Results
In a recently published article in Yahoo News, because of "unacceptably high false-positive test findings" of Ellume's at-home COVID-19 tests, this incident follows a 200,000-kit recall earlier this month for the same problem. It is a class 1 recall, the most dangerous sort, owing to the risk of significant health repercussions or death.
The FDA received 35 false positives from the Ellume COVID-19 Home Test, but no fatalities were recorded, according to the agency. False positives, on the other hand, might result in negative consequences such as receiving unnecessary COVID-19 therapy from a healthcare practitioner or a delayed diagnosis for the person's true condition, according to the FDA.
The FDA said that the problem has no bearing on the credibility of negative test findings. People who have purchased an Ellume home COVID-19 test kit should verify their product by inputting the lot number on this Ellume website, which will identify whether they have one of the affected test kits. On the side of the product box, there is a sticker with the lot number, according to a published report in CBS News.
Ellume Spokesperson Released a Statement
Ellume's production problem has already been resolved, according to a business spokesperson. Ellume has researched the problem, found the fundamental cause, added extra controls, and is now manufacturing and sending new products to the United States.
He also added that the Ellume team expresses its heartfelt regret for any stress or inconvenience caused by a false-positive result. In all circumstances, they have worked tirelessly to assure test accuracy and will continue to do so, as per FOX News.
The recall comes at a time when at-home COVID-19 tests are hard to come by. Many pharmacies are out of stock, and even if they are, the tests would cost about $24 for each pair, which is a significant investment for many customers who need regular testing.
Biden Administration's Deal With Ellume
Ellume announced in May that it was building a manufacturing facility that will be able to produce 19 million tests per month when fully operational. The Biden administration struck a $230 million deal with Ellume in February, and the company announced that it was cobnstructing a manufacturing facility in Frederick, Maryland.
Moreover, while many people would prefer to be able to test for COVID-19 at home, shortages and high prices mean that a number of individuals only check their health status while traveling or attending a particular event. However, the Biden administration said in September that it will spend $1 billion to extend the availability of at-home COVID-19 testing, which might alter in the coming months.
The Ellume COVID-19 Home Test is an antigen test that detects proteins from the COVID-19-causing SARS-CoV-2 virus. Customers must swab the inside of their nostrils for the over-the-counter test. The recalled home tests were made between February 24 and August 11 and delivered between April 13 and August 26 according to the FDA.