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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Sky Medical Supplies and Equipments LLC
Lot Codes / Batch Numbers
2020042901
Products Sold
2020042901
Sky Medical Supplies and Equipments LLC is recalling AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVI due to Distributed COVID test kits without emergency use authorization.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distributed COVID test kits without emergency use authorization.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026