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Thursday, dec 12
Tag:
FDA-authorized SARS-CoV-2 diagnostic test
Business
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…