Class 2 Device Recall OneTouch Ultra Test Strips

• Date Initiated by Firm: November 01, 2005
• Date Posted: January 24, 2006
• Recall Status: Terminated on July 26, 2006
• Recall Number: Z-0435-06
• Recall Event ID: 34272
• 510(K)Number: K043197
• Product Classification: Glucose Oxidase, Glucose - Product Code CGA
• Product: LifeScan OneTouch Ultra Test strips, lot number 2528640
• Code Information: Lot number 2528640, par tnumber 020-245-07, Expiration date April 2006
• FEI Number: 2939301
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6301
• Manufacturer Reason for Recall: Product may be defective and may give low inaccurate glucose results.
• FDA Determined Cause: Other
• Action: Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
• Quantity in Commerce: 7321 boxes of 100 count test strips (29338 vials)
• Distribution: 7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
• 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 = CGA