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U.S. Department of Health and Human Services

Class 2 Device Recall LifeScan OneTouch Ultra Control Solution

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  Class 2 Device Recall LifeScan OneTouch Ultra Control Solution see related information
Date Initiated by Firm February 25, 2013
Date Posted April 17, 2013
Recall Status1 Terminated 3 on October 23, 2013
Recall Number Z-1129-2013
Recall Event ID 64478
510(K)Number K062195  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603.

Testing of Blood Glucose Levels.
Code Information 2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014 
Recalling Firm/
Lifescan Inc
1000 Gibraltar Dr
Milpitas CA 95035-6301
For Additional Information Contact Mr. Jon Mulberg
Manufacturer Reason
for Recall
When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is working properly.
FDA Determined
Cause 2
Nonconforming Material/Component
Action LifeScan sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers may contact OneTouch Healthcare Professional Line at 866-461-0089 for questions about this notice.
Quantity in Commerce 132,301 units total
Distribution Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, 10, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NO, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SO, TN, TX, UT, VA, VI, VT, WA, WI,WV, and WY, and the countries of Russia and Ukraine.
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 = JJX and Original Applicant = LIFESCAN, INC.