LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
- Company
- Lifescan Inc
- Recall Initiated
- November 21, 2003
- Posted
- September 29, 2005
- Terminated
- November 29, 2005
- Recall Number
- Z-1596-05
- Quantity
- Approximately 572,000 units
- Firm Location
- Milpitas, CA
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Includes all System Kits shipped during June 2003 until December 2003
Root Cause
Other
Action Taken
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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