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U.S. Department of Health and Human Services

Class 2 Device Recall AntIbody to SARSCoV2, (Colloidal Gold) for IgG/IgM Diagnostic Kit

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  Class 2 Device Recall AntIbody to SARSCoV2, (Colloidal Gold) for IgG/IgM Diagnostic Kit see related information
Date Initiated by Firm January 19, 2021
Create Date February 16, 2021
Recall Status1 Completed
Recall Number Z-1127-2021
Recall Event ID 87300
Product Classification Reagent, coronavirus serological - Product Code QKO
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.
Code Information 2020042901
Recalling Firm/
Sky Medical Supplies and Equipments LLC
5987 Nw 102nd Ave
Doral FL 33178-2820
For Additional Information Contact Mariana-Kathryn LaParl
Manufacturer Reason
for Recall
Distributed COVID test kits without emergency use authorization.
FDA Determined
Cause 2
No Marketing Application
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.
Quantity in Commerce 10,000 kits
Distribution Worldwide distribution - US Nationwide distribution in the state of Florida and the country of Peru.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.