In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US. 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. https://apple.news/AWwfgaqBFT72Gt2rYUWmx3Q
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.
https://apple.news/AWwfgaqBFT72Gt2rYUWmx3Q
35例假阳性只是reported 的，没reported 没发现的还不知道有多少。这公司应该是自己又检查发现概率不是千分之一这么简单才会recall。