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Class 3 Device Recall HYDRAGEL 15 Hemoglobin (E) |
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Date Initiated by Firm |
August 29, 2006 |
Date Posted |
October 25, 2006 |
Recall Status1 |
Terminated 3 on January 28, 2010 |
Recall Number |
Z-0073-2007 |
Recall Event ID |
36413 |
510(K)Number |
K991362 K963853
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Product Classification |
Hemoglobin kit, in vitro diagnostic - Product Code JBD
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Product |
HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France |
Code Information |
Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03. |
Recalling Firm/ Manufacturer |
Sebia, Inc. 400-1705 Corporate Dr. Norcross GA 30093
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For Additional Information Contact |
Karen Anderson 770-446-3707 Ext. 3704
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Manufacturer Reason for Recall |
The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via fax letter and also by phone contact on or about 08/29/2006. |
Quantity in Commerce |
71 kits |
Distribution |
Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico |
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JBD and Original Applicant = MORAX
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