Recall Z-0944-2022— SML Distribution, LLC

Name: FDA recall Z-0944-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-04

Class I · Ongoing

Class I FDA medical device recall by SML Distribution, LLC, initiated 2022-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test. Reason: The product was distributed without FDA authorization or clearance for marketing and distribution in the US..

Recalling firm: SML Distribution, LLC
Classification: Class I
Status: Ongoing
Initiated: 2022-03-04
Firm location: tyrone, PA, United States

Product description

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Reason for recall

The product was distributed without FDA authorization or clearance for marketing and distribution in the US.

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