Recall Z-1127-2021— Sky Medical Supplies and Equipments LLC
Class II · Terminated
Class II FDA medical device recall by Sky Medical Supplies and Equipments LLC, initiated 2021-01-19, terminated 2026-03-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Distributed COVID test kits without emergency use authorization..
- Recalling firm
- Sky Medical Supplies and Equipments LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-19
- Terminated
- 2026-03-10
- Firm location
- Doral, FL, United States
Product 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.
Reason for recall
Distributed COVID test kits without emergency use authorization.
Data sourced from openFDA. This site is unofficial and independent of the FDA.