Class 3 Device Recall HYDRAGEL 15 Hemoglobin (E)

• Date Initiated by Firm: August 29, 2006
• Date Posted: October 25, 2006
• Recall Status: Terminated on January 28, 2010
• Recall Number: Z-0073-2007
• Recall Event ID: 36413
• 510(K)Number: K991362
• Product Classification: Hemoglobin kit, in vitro diagnostic - Product Code JBD
• 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.
• FEI Number: 3001595416
• Recalling Firm/ Manufacturer: Sebia, Inc.; 400-1705 Corporate Dr.; Norcross GA 30093
• For Additional Information Contact: Karen Anderson; 770-446-3707 Ext. 3704
• Manufacturer Reason for Recall: The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
• FDA Determined Cause: 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

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.

• 510(K) Database: 510(K)s with Product Code = JBD