Class 3 Device Recall OneTouch Ultra Test Strips

• Date Initiated by Firm: October 19, 2005
• Date Posted: December 08, 2005
• Recall Status: Terminated on July 05, 2006
• Recall Number: Z-0273-06
• Recall Event ID: 33943
• 510(K)Number: K043197
• Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code NBW
• Product: LifeScan brand OneTouch Ultra Test strips, 25 strips per vial
• Code Information: Lot number 2591755, part number 020-245-07
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6301
• Manufacturer Reason for Recall: Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
• FDA Determined Cause: Other
• Action: The firm has issued a letter to distributors, along with a Pass-along letter for notifying sub-distribution consignees, as well as letters for end users and a notification letter on its website.
• Quantity in Commerce: 5799 vials
• Distribution: Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.
• 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