Coronavirus: FDA recalls COVID-19 home tests for producing false positives

An Australian company that manufactures an at-home coronavirus test, has recalled nearly 200,000 test kits because of concerns about a higher-than-expected rate of false positives.

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Ellume, which detected the problem in mid-September, said the issue with the test kits could be traced to variations in the quality of one of the raw materials used, Sean Parsons, Ellume’s CEO, told The New York Times in a telephone interview. He declined to specify the material in question, the newspaper reported, citing a desire not to publicly disclose precisely how the test kits work.

The Food and Drug Administration issued a safety bulletin this week, saying that approximately 427,000 of its home tests were being recalled. Approximately 43 lots were distributed to retailers and to the U.S. Department of Defense between April and August, Ellume said in a notice posted on its website. A spokesperson for the Brisbane-based company said that approximately 42,000 affected tests were used and produced positive results.

Parsons said as many as 25% of those positives may have been inaccurate, Parsons told the Times. About 195,000 unused test kits were subject to the recall, according to CBS News. Approximately 160,000 of the tests produced negative results considered reliable, Ellume said.

The kits were sold in the U.S. by retailers including Amazon, CVS, Target and Walmart, CBS News reported.

Ellume’s product is a rapid antigen test, designed to detect the virus in the nose. Users swab their nostrils, insert the swab into a dropper of fluid and then add the fluid to a Bluetooth-connected analyzer, the Times reported. Results are transmitted to a smartphone app in 15 minutes.

In December, it became the first over-the-counter, completely at-home test to receive an emergency use authorization from the Food and Drug Administration, the newspaper reported.

“I’m very sorry that this has happened,” Parsons told the Times. “We’re all about chasing accuracy, and to have these false positives is disappointing.”

Consumers who bought an Ellume kit can check whether it’s part of the recall here, as well as request a replacement test. The company can also be reached Monday through Friday, 9 a.m. to 5 p.m. EDT, at 888-807-1501.

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