Sky Medical Supplies and Equipments LLC recalls AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Ser…
- Recall date
- January 19, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1127-2021
- FDA classification
- Class II
- Brand / firm
- Sky Medical Supplies and Equipments LLC
- Sold / distributed
- Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Why it was recalled
Distributed COVID test kits without emergency use authorization.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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