Device recall
Z-1127-2021: AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic…
FDA device recall · Class II · Sky Medical Supplies and Equipments LLC
Key facts
| Recall number (Z-number) | Z-1127-2021 |
|---|---|
| Recall event | 87300 |
| 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. |
| Product code | QKO |
| Recalling firm | Sky Medical Supplies and Equipments LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 10, 2026 |
| FEI number | 3011895419 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database