Lifescan Inc

Lot number 2591755, part number 020-245-07

Clinical Chemistry and Clinical Toxicology Devices

2

No

Product was distributed to 9 consignees in NY, KY, MO, AL, TN, LA and IL.

LifeScan brand OneTouch Ultra Test strips, 25 strips per vial

Listing Number B026094, Code 90273 Kaban, all demo kits shipped between 04/08/2005 and 08/23/2005

Clinical Chemistry and Clinical Toxicology Devices

2

No

Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution

LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter

Part Number 021-139-01 OT SureSoft Hospital, Regular 200, Lot numbers, SW2764, SW3427, SW2779, SW2785, SW3339, SW3342, SW3394, SW3395.    Part number 021-140-01, OT SureSoft Hospital, Gentle 200, Lot numbers, SW2846, SW2833, SW2774, SW2868, SW2834, SW2765, SW2869, SW2894, SW2896.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Product was distributed to a total of 21 direct consignees and 45 end-user customers, for a total of 66 consignees in both the US and canada.

LifeScan OneTouch SureSoft Lancing Device, single use lancing device.

The following are numbers (kit configurations) are affected by this recall: 010-341-18(OT SureStep system), 010-341-20 (OT SureStep System), 010-341-52 (OT SureStep starter kit), 010-411-06 (OT SureStepE Meter Warranty), 091-041-106 (OT SureStep Meter Warranty PBK).  The following lot numbers are affected: 42711002-01, 42711002-02, 42711002-03, 42731001-01, 42731001-02, 42891003-01, 42901001-01, 42901001-02, 42901001-03, 42911002-01, 42911002-02, 42911002-03, 42921002-01, 42921002-02, 42931001-01, 42931001-02, 42931001-03, 42941001-01, 42941001-02, 42941002-01, 42941002-02, 42941002-03, 42951001-01, 42951001-02, 42951001-03, 42951002-01, 42951002-02, 42951003-01, 42951003-02, 42961001-02, 42961004-01, 42971002-01, 42971002-02, 42971002-03, 42971002-04, 42971002-05, 42971004-01, 42981001-01, 42981001-02, 42981001-03, 42981001-04, 42981001-05, 42981001-06, 42991001-01, 42991001-02, 42991001-03, 43621003-01, 43631001-01, 50051004-01, 50051004-02, 50051004-03, 50061001-01, 50061001-02, 50061001-03, 50081002-01, 50081002-02, 50081002-03, 50091001-01, 50091002-02, 50101001-01, 50101001-02, 50111001-01, 50111002-01, 50121001-01, 50121001-02, 50131001-01, 50131001-02, 50141001-02, 50141001-03, 50171001-04, 50311003-03, 50311003-04, 50321002-01, 50331001-02, 50351002-01, 50351002-02, 50361005-01, 50371001-01, 50371001-02, 50471001-04, 50481001-03.  ***On 4/14/06 the recall was expanded to include meters with Serial Numbers Between L3152Rxxxxxx and L5348Rxxxxxx, 31532002-01 to 53411001-01, 888-845-8904***

Clinical Chemistry and Clinical Toxicology Devices

2

No

Total amount of product distributed in the U.S. is 19,177 units, to distribution centers to be distributed to retailers, Health Care Professionals, wholesalers, and mail order companies. The product was distributed throughout the United States; 29,377 were distributed to Asia, Europe and Latin America.

Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

Part numbers: Verio IQ Systems Kits: 022 267-01, 022 267-01, 022 267-03; Verio IQ Starter Kits: 022 268 01, 022 268-02; Verio IQ Warranty Kits: 022 275 01, 022 275 02. All lots and serial numbers

Clinical Chemistry and Clinical Toxicology Devices

2

No

USA Nationwide Distribution

All OneTouch Verio IQ Blood Glucose Meters sold as: || Verio IQ System Kits - Meter; || Verio IQ Starter kits - Meter; || Verio IQ Warranty Meter. || Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.