Device Recall OneTouch SureStep

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

Clinical Chemistry and Clinical Toxicology Devices

2

No

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.

OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)

Lot codes 2802961 and 2802962

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA and the Caribbean.

OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA

Part Number 01079702, lot numbers 2960713004 2960714009 2960715009 2963504009 2963590009 2963591009 2963592009 2965254009 2965255009 2966650004 2966682009 2966967009 2967057009 2967292009 2967293009 2967849009 2967850009 2967851004 2968029009 2968058004 2968059009 2968060009 2968521008 2968522009 2968523009 2968907009 2969686009 2970097009 2970582009 2975839008 2975840009 2977745008 2977746008 2982027008 2982028008 2982029009 2982366009 2983580009 2984289008 2984956009 2985665008 2985721004 2986875004 2987194009 2987195004 2988277009 2988392009 2990530009 2990940009 2991535009 2992027010 2992293009 2992433011 2992544009 2992695010 2992815010 2992816011 2993127010 2993235010 2993294010 2993295011 2993425011 2993426010 2993599011 2993600011 2993739010 2993991011 2994157010 2994235011 2994236010 2994281004 2994317011 2994463010 2994650010 2994659010 2994704011 2994739010 2994811010 2994812009 2994938011 2998321010 2998322011 2998731011 2999850010 3000111010 3000377011 3000723011 3000724011 3002101010 3002236010 3002237010 3002359010 3003574010 3003632011

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution: USA and countries of Europe, Latin America and Asia.

OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico || Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.