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