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

Recall date

November 28, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0929-2023

FDA classification

Class I

Brand / firm

Universal Meditech Inc.

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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