LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
- Company
- Lifescan Inc
- Recall Initiated
- February 25, 2013
- Posted
- April 17, 2013
- Terminated
- October 23, 2013
- Recall Number
- Z-1129-2013
- Quantity
- 132,301 units total
- Firm Location
- Milpitas, CA
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.
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.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.