Ellume first announced a voluntary recall of some of its rapid antigen tests in October due to an increased chance of false positives. More than 2 million tests are now included in the recall, the US Food and Drug Administration said Wednesday.
This recall has been identified by the FDA as a Class I recall, "the most serious type of recall," as "use of these tests may cause serious adverse health consequences or death." The FDA said false positives could lead to a delayed diagnosis or treatment of the actual cause of a person's illness; receiving unnecessary Covid-19 treatment which may have side effects; and disregard for precautions against Covid-19, including vaccination.
The FDA says that there have been 35 reports of false positives, and no reported deaths. The reliability of negative test results is not affected, the agency said.
Tests manufactured February 24 to August 11 and distributed April 13 to August 26 are included in the recall.
"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 Wednesday.
Ellume is asking that affected products be removed from shelves and not sold; it advises those who have receive a positive result with one of their tests to have a follow up test to confirm their diagnosis.
In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US.
But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.