The U.S. Food and Drug Administration has issued a recall of the Ellume COVID-19 Home Test after determining that about 2 million of the tests have the potential for false positive results.
On Wednesday, the FDA announced that it has classified the recall as a Class I, “the most serious type of recall,” according to a Safety Communications post on the FDA’s website.
“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the FDA statement said.
The public, including test users, caregivers, and health care personnel, was first alerted of the problem, “potential for false positive results with certain lots of the Ellume COVID-19 Home Test,” on Oct. 5, stemming from a “manufacturing issue.”
A false positive is an incorrect test result that “indicates that a person has the virus when they do not actually have it,” the FDA statement said. “Negative results do not appear to be affected by the manufacturing issue.”
The FDA continues to work with Ellume to assess the company’s manufacturing checks and other corrective measures.
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