Z-1130-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- February 25, 2013
- Termination Date
- October 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132,301 units total
Product Description
LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
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 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.
Code Information
2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14