FDA issues warning for Skippack SARS-CoV-2 antigen rapid test

2016 09 02 09 36 05 93 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has issued a safety communication warning against the use of Skippack Medical Lab’s SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).

The FDA said that Skippack Medical has issued a class 1 recall -- the most serious type of recall -- for the test, which has not been authorized, cleared, or approved by the FDA for distribution or use in the U.S. The kit's manufacturer, SML Distribution, has not provided the FDA with adequate data to show that the test works correctly, according to the agency.

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