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U.S. Department of Health and Human Services

Class 3 Device Recall OneTouch Data Management Software v1.0

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  Class 3 Device Recall OneTouch Data Management Software v1.0 see related information
Date Initiated by Firm December 18, 2007
Date Posted April 08, 2008
Recall Status1 Terminated 3 on July 18, 2008
Recall Number Z-1317-2008
Recall Event ID 46398
510(K)Number K984527  
Product Classification Glucose test system - Product Code NBW
Product LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
Code Information Part Number: 021-722-01
Recalling Firm/
Manufacturer		 Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6312
For Additional Information Contact
408-942-5903
Manufacturer Reason
for Recall		 Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
FDA Determined
Cause 2		 Software design
Action The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250.
Quantity in Commerce 260 units
Distribution Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI.
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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