Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1127-2021 — 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.

U.S. FDA — Device Enforcement · United States · 2021-01-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1127-2021
Date of alert
2021-01-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Sky Medical Supplies and Equipments LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2020042901
Reported risk: Distributed COVID test kits without emergency use authorization.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.