Lower risk Medical device recall · FDA · Published January 19, 2021

Sky Medical recalls SARS-CoV-2 rapid test kits without emergency authorization

Sky Medical recalls IgG/IgM diagnostic test kits for SARS-CoV- 2 that were distributed without emergency use authorization. This recall addresses potential risks from unapproved testing devices.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1127-2021Medical device Sky Medical ›

Lower-risk recall

Distributed COVID test kits without emergency use authorization.

Take action

Contact the company

Recalling firmSky Medical Supplies and Equipments LLC5987 Nw 102nd Ave · Doral, FL 33178-2820

✎ GovInfoNow plain-language explainer

Sky Medical is recalling SARS-CoV-2 rapid test kits that were distributed without emergency use authorization. This means the tests may not be safe or reliable, and users should not rely on them for accurate results. Read more at govinfonow.com/recall/63362-sky-medical-recalls-sars-cov-2-rapid-test-kits-without.

Source Summary by GovInfoNow · govinfonow.com/recall/63362-sky-medical-recalls-sars-cov-2-rapid-test-kits-without · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1127-2021

Cite this page

“Sky Medical recalls SARS-CoV-2 rapid test kits without emergency authorization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63362-sky-medical-recalls-sars-cov-2-rapid-test-kits-without. Based on FDA recall #Z-1127-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2021%22&limit=1).

Sky Medical Supplies and Equipments LLC voluntarily recalled its AntIbody to SARS-CoV-2 diagnostic kits on Jan. 19, 2021, after distributing them without emergency use authorization, the FDA said.

How to tell if you have it

Brand: Sky Medical
Product: AntIody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE
Lot code: 2020042901
Quantity: 10,000 kits

The hazard

The company distributed the rapid test devices for whole blood, serum, or plasma without obtaining the necessary emergency use authorization from federal regulators.

Context

GovInfoNow's records show other recent recalls of similar diagnostic products include the GET TESTED Urinary Tract Infection Test Recall (2025-11-03), the GET TESTED H. pylori Test Recall (2025-11-03), and the GET TESTED Iodine Test (2025-11-03).

How to tell if you have this one

The product is labeled as 'AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma'. It was sold by Sky Medical Supplies and Equipments LLC starting from the date indicated in the recall.

Brand
Sky Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product name and manufacturer details on the test kit to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 5.1 years after the firm started it.

Jan 19, 2021Firm started the recall
Feb 16, 2021FDA classified it Class II
Feb 24, 2021Published in FDA’s Enforcement Report
Mar 10, 2026FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Sky Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/63362-sky-medical-recalls-sars-cov-2-rapid-test-kits-without">Sky Medical recalls SARS-CoV-2 rapid test kits without emergency authorization (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1127-2021 (January 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1127-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.