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.
FDA Recall Z-1127-2021 · Posted None
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Recalling FirmSky Medical Supplies and Equipments LLC
Recall StatusTerminated
Product CodeQKO
Date Initiated2021-01-19
Date Terminated2026-03-10
Product Quantity10,000 kits
Reason for Recall
Distributed COVID test kits without emergency use authorization.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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