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# Don’t Use Skippack Covid Rapid Test: FDA
- URL: https://www.fdaweb.com/dont-use-skippack-covid-rapid-test-fda/
- Published: 2022-05-10T12:00:00.000Z
- Updated: 2026-09-14T17:43:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151785

FDA is cautioning against the use of the Skippack Medical Lab (SML) SARS-CoV-2 Antigen rapid test. An agency [notice](https://www.fda.gov/medical-devices/safety-communications/do-not-use-skippack-medical-lab-sars-cov-2-antigen-rapid-test-fda-safety-communication?ref=fdaweb.com) says the test is not authorized, cleared, or approved by FDA for distribution or use in the United States because SML Distribution has not provided FDA with adequate data to show the test works correctly. FDA says it has not received reports of injuries or death associated with using the Skippack test.

The test has been recalled by the manufacturer, a separate FDA [notice](https://www.fda.gov/medical-devices/medical-device-recalls/sml-distribution-llc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not?ref=fdaweb.com) says, and the recall is Class 1\. The notice says Skippack initiated the recall on 3/4 for up to 209,450 units distributed in the U.S. between 1/21 and 2/11.