Class 3 Device Recall OneTouch Data Management Software v1.0

• Date Initiated by Firm: December 18, 2007
• Date Posted: April 08, 2008
• Recall Status: Terminated on July 18, 2008
• Recall Number: Z-1317-2008
• Recall Event ID: 46398
• 510(K)Number: K984527
• Product Classification: Glucose test system - Product Code NBW
• Product: LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
• Code Information: Part Number: 021-722-01
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6312
• For Additional Information Contact: 408-942-5903
• Manufacturer Reason for Recall: Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
• FDA Determined Cause: Software design
• Action: The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.
• Quantity in Commerce: 260 units
• Distribution: Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.
• 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