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The U.S. Food and Drug Administration (FDA) is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). 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 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).
Do not use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
The unauthorized Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) uses a nasal swab sample to detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19. It uses one of two types of swab samples: nasal (anterior nares) or nasopharyngeal.
The FDA has classified the recall for these tests as a Class I recall, the most serious type of recall.
The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is providing this information to help educate test users, caregivers, health care personnel, and the public and to reduce the risk of false test results that could lead to serious illness and death.
The FDA will keep the public informed if significant new information becomes available.
If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Malaria Nucleic Acid Detection Kit If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.