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# Universal Meditech Recalls Covid Tests
- URL: https://www.fdaweb.com/universal-meditech-recalls-covid-tests/
- Published: 2023-02-08T12:00:00.000Z
- Updated: 2026-09-14T18:15:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153736

Universal Meditech has recalled (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they were distributed to U.S. customers without FDA authorization, clearance or approval. “Neither Universal Meditech Inc. nor SML Distribution LLC, has provided the FDA with adequate data to show that the test’s performance is accurate,” an agency [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not?utm%5Fmedium=email&utm%5Fsource=govdelivery) says, adding that this could lead to a false negative, false positive, or misinterpretation of results.

The test uses patient samples to detect antigens related to the SARS-CoV-2 virus. The samples are collected by nasal or nasopharyngeal swab.