Sky Medical Supplies and Equipments LLC Recall 87300
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.
Sky Medical Supplies and Equipments LLC Recall 87300 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1127-2021 |
Event ID | 87300 |
Event 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. |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru. |
Quantity | 10,000 kits |
Recall Reason | Distributed COVID test kits without emergency use authorization. |
Device Classification | 20210224 |
Device Code Info | 2020042901 |
Center Classification Date | 20210216 |
Recall Initiation Date | 20210119 |
Recalling Firm | Sky Medical Supplies and Equipments LLC |
Initial Notification | Telephone |
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