(Trends Wide) — The Ellume company recalled more than 2 million covid-19 tests for home use due to a “higher than acceptable” number of false positives.
Ellume first announced in October the voluntary departure of some of its rapid antigen tests due to an increased likelihood of false positives. The US Food and Drug Administration (FDA) reported Wednesday that more than two million tests are included in the recall.
The measure was identified by the FDA as a Class I recall, “the most serious type of recall,” as “the use of these tests can cause serious adverse health consequences or death.” The FDA noted that false positives could cause a delay in the diagnosis or treatment of the actual cause of a person’s illness; receiving unnecessary covid-19 treatment that could have side effects; and cause COVID-19 precautions, including vaccination, to be ignored.
The FDA states that there have been 35 false positive reports, and no deaths have been reported. The reliability of negative test results is not affected, according to the agency.
Tests manufactured between February 24 and August 11 and distributed between April 13 and August 26 are included in the recall.
“The FDA continues to work with Ellume to evaluate the company’s actions, such as additional manufacturing controls and other corrective actions, to address the reason for the manufacturing issue and help ensure that it is resolved and not repeated,” he said. the agency this Wednesday.
Ellume calls for the affected products to be removed from the shelves and not sold; advises those who have had a positive result with one of his tests to undergo a follow-up test to confirm their diagnosis.
In February, the Biden administration announced an allocation of US $ 231.8 million to Ellume USA for the production of its home tests for use in the United States.
But the demand for home tests has remained high and the supply limited. This fall, the Biden administration announced billions of dollars more to help make more evidence available.
