Home Covid Tests by Ellume Recalled Over False-Positive Reports

(Bloomberg) -- After complaints to U.S. regulators about false positives from a startup’s at-home Covid-19 test, the Australian company investigated and recalled hundreds of thousands of kits sold through stores and online, the U.S. Food and Drug Administration said. 

Ellume Ltd. late last week announced a voluntary recall of about 195,000 tests that remained unused. Around 427,000 total tests were affected by a test component that left them more likely to return a false positive, a company spokeswoman said. 

“I offer my sincere apologies -- and the apologies of our entire company -- for the stress or difficulties people may have experienced due to a false positive result,” Sean Parsons, chief executive officer of East Brisbane-based Ellume, said in a statement. 

The recall is a setback for rapid virus screening and could undermine faith in the tests just as the Biden administration is seeking to expand availability of them. 

About 18% of the affected test kits used produced positive results, according to numbers provided by the company. It isn’t clear how many were true positives. The faulty tests made up about 12% of the millions of tests that Ellume has sent to the U.S.

Ellume’s self-administered, single-use test is similar to an over-the-counter pregnancy test. Sold for about $30, it uses a swab to detect proteins known as antigens on the virus’s surface and returns results in 15 minutes using an app. 

The test was the first such product to be authorized for use without a prescription by the FDA, and the company has only distributed its test kits to the U.S., the spokeswoman said. The Biden administration invested $232 million in expanding Ellume’s production of the tests early this year. 

While no test can be completely accurate, false positives can lead to unnecessary quarantines, keeping users home from work and school. 

White House Moves

The White House plans to announce a $1 billion purchase of rapid at-home tests on Wednesday, on top of a previous $2 billion purchase of similar quick-turnaround screenings. 

The Ellume test issue “is expected to be resolved with additional manufacturing checks and corrective actions,” FDA spokesman James McKinney said. “Manufacturing issues can arise with any medical device, including tests. This is one of the reasons why the FDA has a robust post-market surveillance program.”

FDA monitoring found user complaints about false positives in late August, and the agency began actively working with the company, McKinney said. Ellume is still investigating, and additional information will be released if more tests turn out to have been affected, according to the FDA. 

The FDA warned the public about the potential for false positives with certain affected lots of the tests on Tuesday. 

The FDA’s database of medical-device issues, called Maude, lists three reports about the Ellume test in recent months. All three said they had false positive results. One report said that a child had missed at least two days of school because of a false positive. Another said that after getting a positive result, four subsequent tests returned negative. 

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