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COVID-19: New Recall Issued For Rapid Tests, FDA Says COVID-19: New Recall Issued For Rapid Tests, FDA Says
Covid-19: New Recall Issued For Rapid Tests, FDA Says A new recall has been issued for some COVID-19 rapid tests that are not authorized for distribution, the US Food and Drug Administration announced on Tuesday, May 10. The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). Click here for the product codes. "This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States," said the FDA, noting it "is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the t…

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by Joe Lombardi
News
COVID-19: FDA Announces New At-Home Test Recall COVID-19: FDA Announces New At-Home Test Recall
Covid-19: FDA Announces New At-Home Test Recall Federal health officials are cautioning Americans not to use a specific COVID-19 at-home testing kit that has not been approved or authorized by medical authorities. The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), are advising against the use of the LuSys Laboratories COVID-19 Antigen Test because they have not been cleared for use. In total, nearly 165,000 at-home kits are subject to the recall, according to the FDA. Officials said that the LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to de…

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by Zak Failla
News
COVID-19: FDA Warns Against Using These At-Home Tests COVID-19: FDA Warns Against Using These At-Home Tests
Covid-19: FDA Warns Against Using These At-Home Tests With the use of at-home COVID-19 testing on the rise, federal health officials are cautioning about two kits that may produce false negative or positive results. The Food and Drug Administration (FDA) issued a warning about using the “Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test” and “ImmunoPass COVID-19 Neutralizing Antibody Rapid Test” due to mislabeling. According to authorities, the tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved for distribution or use in the US. Empowered Diagnost…

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by Zak Failla