NEW YORK – The US Food and Drug Administration warned against the use of Skippack Medical Lab's SARS-CoV-2 antigen test on Tuesday, according to a notice on the agency's website.
The Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) has not been authorized, cleared, or approved for distribution or use in the US. The FDA noted that it is concerned about false results from the test because SML Distribution, the company providing the test, hasn't submitted adequate data to the agency proving the test works correctly.
The company began a Class I recall, the most serious type of recall, of the tests in March.
The FDA said it hasn't received reports of injuries or death associated with the use of the test but recommended that healthcare providers who had tested patients with the assay in the past two weeks consider retesting the patients with a test that has been authorized by the agency.