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Ellume is recalling about 2.2 million of its home coronavirus tests because of false positive test results, the FDA said in a news release.

The recall is an expansion of the recall of about 200,000 Ellume home tests in October because of the same problem, the agency said.

The FDA said it knew of 35 false-positive results, none of which resulted in death. False-positive results show a person has the virus when they actually don’t. A danger of false positives is that they can lead to delayed diagnosis of the person’s actual health problem, the FDA said.

The reliability of negative test results is not in question, the release said.

In a statement, Ellume CEO Sean Parsons, MD, apologized to consumers and said the problem was limited to specific lots. Ellume told CBS MoneyWatch that it had identified the problem and set up additional controls.

People should go to the Ellume website to see if the home COVID test they purchased is included in the recall. The product’s lot number is found on a sticker on the side of the product. Consumers can also call 888-807-1501 or email [email protected].

This is a class I recall, “the most serious type of recall. Use of these tests may cause serious adverse health consequences or death,” the FDA said.

The Ellume test is the first over-the-counter home COVID-19 test given emergency use authorization by the federal government.

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