Class 2 Device Recall OneTouch SureStep Pro Test Strips

• Date Initiated by Firm: September 29, 2006
• Date Posted: January 05, 2007
• Recall Status: Terminated on November 27, 2007
• Recall Number: Z-0453-2007
• Recall Event ID: 36774
• 510(K)Number: K023194
• Product Classification: Blood Glucose test strips - Product Code CGA
• Product: LifeScan brand One Touch -Sure Step Pro- Blood Glucose Monitoring System Test Strips, 50 strips per package,; ; Distributed and Manufactured by: LifeScan, Inc., ; 1000 Gibraltar Drive, Milpitas, CA 95037
• Code Information: Lot number 2634187008, Part number 010-797-02
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Dr; Milpitas CA 95035-6312
• Manufacturer Reason for Recall: Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.
• FDA Determined Cause: Other
• Action: The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.
• Quantity in Commerce: 26,398 units (both recall numbers Z-0452/3-2007
• Distribution: Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.
• 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 and Original Applicant = LIFESCAN, INC.