The US Food and Drug Administration issued “the more serious kind” of call back” for popular home test kit that show Self one is infected with coronavirus. At least 2.2 million products could have been viewed false positive.
Approximately 2,212,335 kits produced by the Australian biotech company Ellume and distributed in the United States potentially show false SARS-CoV-2 positive positive test results, the public the health agency said in a declaration on Thursday.
The FDA has warned that the use of defective kits “May cause serious adverse health consequences o death” identifying the case as “Class I remember”.
The antigen test, which detects coronavirus proteins, has been cleared for emergency use by the FDA last year. And available without prescription for both adults and children aged two years or older and uses swab samples taken from a nose to detect whether one has covid. Some “specific batches”, produced between February and August this year, they are now recalled in the United States, with the company says it worked with authorities to voluntarily remove i test affected by market. The company offered its apology “for any stress or difficulty [customers] may have experienced why of a false positive result. ”
The “higher-that-acceptable “ false results, showing that a person has the coronavirus when in reality they don’t, they have been reported to the FDA in at least 35 cases. No false negative results have been detected. However, inaccurate diagnosis could have life-threatening consequences. A person could receive wrong or unnecessary treatment, including with antiviral and antibody therapy and suffer further trauma over having to isolate yourself from family members and friends. Could also lead to people ignoring precautions, including getting vaccinated against Covid-19, the FDA said.
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