# FDA recall Z-1127-2021

> **Sky Medical Supplies and Equipments LLC** · Class II · device recall initiated 2021-01-19.

## Product

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.

## Reason for recall

Distributed COVID test kits without emergency use authorization.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.

## Key facts

- **Recall number:** Z-1127-2021
- **Recalling firm:** Sky Medical Supplies and Equipments LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-19
- **Report date:** 2021-02-24
- **Termination date:** 2026-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Doral, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2021

## Citation

> AI Analytics. FDA recall Z-1127-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1127-2021. Source: US FDA. Licensed CC0.

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