FDA Device

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

Hazard

LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.

What You Should Do

Remedy

Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet.

Products

LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
Brand
Lifescan Inc
UPC
Includes all System Kits shipped during June 2003 until December 2003

Units Affected

Approximately 572,000 units