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.
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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