Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) Recalled by SML Distribution, LLC Due to The product was distributed without FDA authorization or...

Date: March 4, 2022
Company: SML Distribution, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact SML Distribution, LLC directly.

Affected Products

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

Quantity: 209,450 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About SML Distribution, LLC

SML Distribution, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report