USA Medical, LLC recalls Diagnostic Kit SARS-cCo V Antigen Rapid Test

Recall date

April 4, 2022

Source

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

Recall number

Z-1050-2022

FDA classification

Class II

Brand / firm

USA Medical, LLC

Sold / distributed

U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.

Why it was recalled

COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Diagnostic Kit SARS-cCo V Antigen Rapid Test