Skippack SARS-CoV-2 Antigen Rapid Test Recalled

5/10/22 — SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold). The FDA has identified this issue as a Class I recall, the most serious type of recall, because this test is not authorized, cleared, or approved by the FDA for distribution or use in the United States. The FDA 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 tests work correctly. Read more.