Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Recalled by Sky Medical Supplies and Equipments LLC Due to Distributed COVID test kits without emergency use authorization.

Date: January 19, 2021
Company: Sky Medical Supplies and Equipments LLC
Status: Terminated
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 Sky Medical Supplies and Equipments LLC directly.

Affected Products

AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

Quantity: 10,000 kits

Why Was This Recalled?

Distributed COVID test kits without emergency use authorization.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sky Medical Supplies and Equipments LLC

Sky Medical Supplies and Equipments LLC has 1 total recall tracked by RecallDetector.

Related Recalls

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