Nearly 200,000 COVID Home Tests Recalled Over False Positives
Wednesday, 06 October 2021 02:55 PM
Almost 200,000 Ellume COVID-19 home testing kits have been recalled because they may be more likely to give a false positive result.
The problem with the rapid antigen tests was identified in mid-September and caused by variations in the quality of one of the raw materials used in the products, Ellume CEO Dr. Sean Parsons told The New York Times.
The Ellume test kits received emergency use authorization from the U.S. Food and Drug Administration last December, and the Australian company had already shipped about 3.5 million of the test kits to this country.
About 427,000 of those kits were affected by the problem, and about half have already been used, returning about 42,000 positive results, Parsons told the Times.
He said it would be difficult to determine how many of those positive results may have been incorrect, but said the rate could be as high as one quarter.
...
READ MORE: https://www.newsmax.com/health/health-news/covid-test-home-rapid-antigen/2021/10/06/id/1039369/