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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - FDA Safety Communication

Today, the FDA is warning people to not 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 tests work 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 issued a safety communication to provide:

• Recommendations for test users, caregivers, and health care personnel. 
• Details on the issue and the FDA’s actions to address the issue.
• Instructions for reporting problems with tests to the FDA.

 Questions?

If you have questions, contact the Division of Industry and Consumer Education (DICE).