Class 2 Device Recall FreeStyle Flash

• Date Initiated by Firm: May 22, 2006
• Date Posted: August 03, 2006
• Recall Status: Terminated on December 21, 2006
• Recall Number: Z-1307-06
• Recall Event ID: 35486
• 510(K)Number: K051839 K992684
• Product Classification: Blood Glucose Meter - Product Code NBW
• Product: Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
• Code Information: All codes.
• Recalling Firm/ Manufacturer: Abbott Diabetes Care, Inc.; 1360 S Loop Rd; Alameda CA 94502-7000
• Manufacturer Reason for Recall: The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
• FDA Determined Cause: Other
• Action: On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
• Quantity in Commerce: 2,365,000 meters (approx.-both types
• Distribution: Worldwide
• 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 = NBW