More than 2 million Ellume Covid-19 home tests recalled due to false positives – Community News

More than 2 million Ellume Covid-19 home tests recalled due to false positives

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 U.S. Food and Drug Administration said Wednesday.
US lags behind Covid tests at home

This recall has been identified by the FDA as a Class I recall, “the most serious type of recall,” because “the use of these tests could cause serious adverse health effects or death.” The FDA said false positives can delay diagnosis or treatment of the true cause of a person’s illness; getting unnecessary Covid-19 treatment that can have side effects; and ignoring precautions against Covid-19, including vaccination.

The FDA says there are 35 reports of false positives and no reported deaths. The reliability of negative test results is not affected, the agency said.

Tests produced from February 24 to August 11 and distributed from April 13 to August 26 are included in the recall.

Covid-19 test at home to ramp up production with $231.8 million federal contract

“The FDA continues to work with Ellume to review the company’s corrective actions, such as additional manufacturing controls and other corrective steps, to address the reason for the manufacturing problem and to ensure it is resolved and will not reoccur,” says the FDA. The agency reported this on Wednesday.

Ellume asks that the affected products be taken off the shelves and not sold; it advises those who have received 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 to Ellume USA for the production of its US home tests.
But the demand for home testing has remained high and the supply limited. This fall, the Biden administration announced billions of additional dollars to make more tests available.