Reported Feb 24, 2021 · Terminated

AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole…

Sky Medical Supplies and Equipments LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sky Medical Supplies and Equipments LLC · 5987 Nw 102nd Ave · Doral, FL · 33178-2820

Is this the product you have?

  • 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
Lot codes and dates
  • 2020042901
Amount recalled
10,000 kits

Where it was sold

  • Nationwide
  • FL

Why it was recalled

Distributed COVID test kits without emergency use authorization.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 10, 2026 · Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.