FDA issues ‘do not use’ warning for another unauthorized COVID-19 rapid test

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The FDA said the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) has been recalled.

about the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test because it “is not authorized, cleared, or approved by the FDA for distribution or use in the United States.”

The FDA said it is concerned about the risk of receiving false results because the company, SML Distribution LLC, “has not provided the FDA with adequate data to show the test works correctly.”The test uses a nasal swab to detect the proteins from the virus that causes

 

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