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U.S. Department of Health and Human Services

Class 1 Device Recall Lifescan OneTouch Ultra Meter

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  Class 1 Device Recall Lifescan OneTouch Ultra Meter see related information
Date Initiated by Firm November 21, 2003
Date Posted September 29, 2005
Recall Status1 Terminated 3 on November 29, 2005
Recall Number Z-1596-05
Recall Event ID 31815
510(K)Number K024194  
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product LifeScan brand OneTouch Ultra Meter - Owner''s Booklet;
Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037
Code Information Includes all System Kits shipped during June 2003 until December 2003
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
For Additional Information Contact Mario Lowes
408-956-4087
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce Approximately 572,000 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = LIFESCAN, INC.
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