Universal Meditech Inc. recalls Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT

Recalled February 8, 2023 · FDA recall Z-0929-2023 · Universal Meditech

Hazard

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization. · FDA Class I

Units

56,300 kits

Sold at

U.S. Nationwide distribution in the states of CA, and TX.

Description

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Product

Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING

Manufacturer(s)

Universal Meditech Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →