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/ Manufacturer |
Sky Medical Supplies and Equipments LLC 5987 Nw 102nd Ave Doral FL 33178-2820
|
For Additional Information Contact |
Mariana-Kathryn LaParl 786-667-2955
|
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
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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.
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