WASHINGTON — The Food and Drug Administration is warning to avoid using another at-home COVID-19 that could give a wrong result when used.
Do not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold), according to an agency alert published Tuesday.
“This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States,” the FDA said, adding that it “is concerned about the risk of false results when using this test.”
Up to more than 209,000 of these tests were recalled by SML Distribution LLC after they were distributed in the U.S. in January and February, the FDA said. The agency emphasized this is a “Class I recall, the most serious type.”
SML Distribution has not given “adequate data to show the test works correctly,” according to the FDA.
The company acknowledged in a recall statement that a false test result “can lead to unnecessary quarantine and testing resources” if it leads a person to believe they are COVID-19 positive when they are not sick.
Additionally, a false negative result “may lead to delayed diagnosis or inappropriate treatment,” the FDA said. This could result in “harm including serious illness and death” and spreading COVID-19 to others.
The recalled test involves a nasal swab to detect the virus, according to the FDA.
If you or someone you know was recently tested with this unauthorized test, the agency suggests raising concerns with a health care provider.
Health workers who have tested patients using the test within the past two weeks should “consider retesting your patients,” the FDA advises.
Over the past several months, the FDA has issued a number of alerts about certain at-home COVID-19 tests to avoid using.
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