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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 test works correctly."
SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), and the FDA has identified this issue as a Class I recall, the most serious type of recall.
The FDA has not received reports of injuries or death associated with use of the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
The FDA is recommending:
Test users and caregivers: Talk to your health care provider if you were tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) and you have concerns about your test results.
Health care personnel: If your patient was tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) in the last 2 weeks and you suspect an inaccurate result, consider retesting your patients using an FDA-authorized SARS-CoV-2 diagnostic test. If testing was performed more than two weeks ago, and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
Report any problems you experience with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) to the FDA, including suspected false results, by visiting here.
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