Recall Z-1127-2021 ยท QKO Reagent, Coronavirus Serological
Sky Medical Supplies and Equipments LLC
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.
| Date | Jan 19, 2021 |
| Status | Terminated |
| Reason | Distributed COVID test kits without emergency use authorization. |
| Root cause | No Marketing Application |
| Action | Sky Medical initiated the recall on 01/19/2021 by telephone. The firm sent a follow-up letter disseminated by email on 02/03/2021. The firm is requesting the return of the product. |
| Quantity | 10,000 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.