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Medical Device Recall Database Entry

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COVID-19: High False-Positive Rate Leads To Recall Of 2 Million-Plus Home Tests For Virus COVID-19: High False-Positive Rate Leads To Recall Of 2 Million-Plus Home Tests For Virus
Covid-19: High False-Positive Rate Leads To Recall Of 2 Million-Plus Home Tests For Virus The Food and Drug Administration has announced more than two million COVID-19 home tests have been recalled due to a high false-positive rate.  The Ellume COVID-19 Home Test is available without a prescription for use by people with or without COVID-19 symptoms. The test uses swab samples taken from further up inside the nose but not as deep inside the nose to reach the back of the throat where a health care professional collects a sample, the FDA said, noting the Ellume test uses an analyzer that connects with a smartphone app to show users how to perform the test and understand the t…

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by Joe Lombardi