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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