Z-1127-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- March 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,000 kits
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Code Information
2020042901