OneTouch Ultra

Includes all System Kits shipped during June 2003 until December 2003

Clinical Chemistry and Clinical Toxicology Devices

2

No

The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003.

LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; || Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

Lot number 2528640, par tnumber 020-245-07, Expiration date April 2006

Clinical Chemistry and Clinical Toxicology Devices

2

No

7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.

LifeScan OneTouch Ultra Test strips, lot number 2528640

Clinical Chemistry and Clinical Toxicology Devices

In-vitro diagnostics

In-vitro diagnostics

Press release: DH Closely Monitoring Safety of Lifescan Blood Glucose Meter