Product Description LifeScan brand OneTouch® Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.

Recall Number Z-1129-2013

Classification Class II

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

Product Distributed Qty 132,301 units total

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.

Event Id 64478

Product Type Devices

Status Ongoing

Recalling Firm Lifescan Inc, Milpitas, Ca, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-02-25

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern 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.