Home Covid tests recalled over false positives reaches 2 million sets.

The Australian company Ellume has extended the recall of its home coronavirus test due to concerns about a “higher than acceptable” rate of false positives, the US Food and Drug Administration said on Tuesday.

The recall now includes about 2 million of the 3.5 million test kits that Ellume had sent to the United States last month, a significant increase from the company’s previous estimates that around 427,000 of these kits were potentially defective.

It is not clear how many false positives the affected tests have given. The problem, which the company had previously traced to a problem with one of the raw materials used in the test kits, does not affect the reliability of negative results.

The FDA categorized the recall, which was first announced last month, as Class I, the most serious type. Use of the tests could have “serious adverse health consequences,” the agency said. People who mistakenly test positive for the virus may receive unnecessary treatments for Covid-19 and experience delays in being diagnosed with and treated for “the actual cause of the person’s illness,” the agency noted.

“Ellume has investigated the problem, identified the root cause, implemented additional controls, and we are already producing and shipping new products to the United States,” said a company representative. “It is important that not all of the positive results from the affected tests were false positive, and negative results were not affected by this problem.”

Many of the affected test kits have already been used. Consumers can find out if they have used or purchased one of the affected tests, and ask for a replacement, online.

Those who try to use one of the affected test sets will be notified in the app that the test has been revoked. “It really will not be possible to use any of these tests now,” Dr. Sean Parsons, Ellume’s CEO, said in an interview last month.

The company has taken further precautions to prevent the problem from recurring, he added.

“I’m very sorry this happened,” said Dr. Parsons. “We’re about chasing accuracy, and having those false positives is disappointing.”

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