Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week. Ellume last month recalled certain lots of its COVID-19 Home Test due to an increased chance of false-positive results. FDA has classified the recall as a Class I recall, the most serious type.

“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 agency said.

 

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