Home / Recalls / Medical Devices
Sky Medical Supplies and Equipments LLC recalls AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Seru
Recalled February 24, 2021 · FDA recall Z-1127-2021 · Sky Medical Supplies and Equipments
Hazard
Distributed COVID test kits without emergency use authorization. · FDA Class II
Units
10,000 kits
Sold at
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Description
Distributed COVID test kits without emergency use authorization.
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.
Manufacturer(s)
Sky Medical Supplies and Equipments LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →