Drug recall
AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole…
FDA recall event 87300 · Class II · Sky Medical Supplies and Equipments LLC
Key facts
| Event ID | 87300 |
|---|---|
| Recall numbers | Z-1127-2021 |
| Recalling firm | Sky Medical Supplies and Equipments LLC |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Distributed COVID test kits without emergency use authorization. |
| Initiation date | Jan 19, 2021 |
| Report date | Feb 24, 2021 |
| City | Doral |
| State | FL |
| Country | United States |
| FEI number | 3011895419 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: