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.
Reported: February 24, 2021 Initiated: January 19, 2021 #Z-1127-2021
Product Description
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.
Details
- Recalling Firm
- Sky Medical Supplies and Equipments LLC
- Units Affected
- 10,000 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
- Location
- Doral, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sky Medical Supplies and Equipments LLC. Units affected: 10,000 kits.
Why was this product recalled? ▼
Distributed COVID test kits without emergency use authorization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1127-2021.
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