Class 2 Device Recall OneTouch SureStep

• Date Initiated by Firm: January 13, 2003
• Date Posted: March 12, 2003
• Recall Status: Terminated on August 21, 2003
• Recall Number: Z-0630-03
• Recall Event ID: 25381
• 510(K)Number: K970556
• Product Classification: Glucose test strips - Product Code CGA
• Product: OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
• Code Information: Test Strips with Off-Center Confirmation Dot Part Number Lot Number Exp. Date Description 010-797-02, 191303A005, 10/03, SureStepPro Strips (50), 010-797-02, 192113A005, 10/03, SureStepPro Strips (50), 010-797-02, 194382A004, 11/03, SureStepPro Strips (50), 020-052-01, E-187250A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-03, E-187250B, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-189831A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-192063A, 10/03, 100-Count OneTouch SureStep Test Strips, 010-359-04, G-190477A, 10/03, 50-Count OneTouch SureStep Test Strips, 020-052-01, E-182852A, 5/03, 100-Count OneTouch SureStep Test Strips, Defective Test Strip Bottle Cap Part Number Lot Number Exp. Date Description 010-797-02, 205206A004, 02/04, 50-Count SureStepPro Test Strips, 010-797-02, 205913A012, 03/04, 50-Count SureStepPro Test Strips, 010-797-02, 205946A004, 03/04, 50-Count SureStepPro Test Strips, 020-052-02, F-204252B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204296A, 1/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204620A, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204668B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-205519A, 3/04, 100-Count OneTouch SureStep Test Strips, 010-359-04, H-204583A, 12/03, 50-Count OneTouch SureStep Test Strips, 010-359-04, H-205890B, 3/04, 50-Count OneTouch SureStep Test, Strips ------------- F-204098B, 2/04, 50-Count OneTouch SureStep Medicare Test Strips
• Recalling Firm/ Manufacturer: Lifescan Inc; 1000 Gibraltar Drive; Milpitas CA 95035-6312
• For Additional Information Contact: Mario Lowes; 408-956-4087
• Manufacturer Reason for Recall: The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.
• FDA Determined Cause: Other
• Action: Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.
• Quantity in Commerce: 3,679,000 units
• Distribution: Distribution of the product is worldwide and nationwide. Distribution in the United States was between April/02 to June/02. U.S. Government/Military or Canadian distribution is unknown at this time.
• 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