FDA Issues Safety Alert for COVID-19 Test Over Concerns of False Results

The Food and Drug Administration (FDA) has issued a safety communication warning individuals to stop using the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as it has not been authorized, cleared, or approved for distribution or use in the United States.

In the safety communication, the FDA noted that the use of this unauthorized test may increase the risk of false results because SML Distribution LLC has not provided adequate data to show that the test’s performance is accurate. The FDA has designated this a Class I recall, the most serious type.

SML Distribution LLC is recalling the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). To date, there have been no reports of injuries or death associated with the use of this test.

Health care providers should consider retesting patients who were tested with the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test in the last 2 weeks if an inaccurate result is suspected. 

Issues related to SARS-CoV-2 testing should be reported through the FDA’s MedWatch Voluntary Reporting Form.

References

1. Do not use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA safety communication. News release. US Food and Drug Administration. Accessed May 12, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-skippack-medical-lab-sars-cov-2-antigen-rapid-test-fda-safety-communication
2. SML Distribution LLC recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests that are not authorized, cleared, or approved by the FDA. News release. US Food and Drug Administration. Accessed May 12, 2022. https://www.fda.gov/medical-devices/medical-device-recalls/sml-distribution-llc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not