Recall Z-1050-2022— USA Medical, LLC

Name: FDA recall Z-1050-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-04

Class II · Ongoing

Class II FDA medical device recall by USA Medical, LLC, initiated 2022-04-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Diagnostic Kit SARS-cCo V Antigen Rapid Test. Reason: 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..

Recalling firm: USA Medical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-04
Firm location: Grapevine, TX, United States

Product description

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.