Doral, FL, United States
Sky Medical Supplies and Equipments LLC recalls
1 recall recorded since 2018, most recently on 19 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 19 January 2021
- Terminated
- 10 March 2026
- Reason
- Distributed COVID test kits without emergency use authorization.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1127-2021
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.