Home / Recalls / Lifescan Inc / Z-1130-2013

Z-1130-2013 Class II Terminated

Recalled by Lifescan Inc — Milpitas, CA

FDA device recall Z-1130-2013 was initiated by Lifescan Inc on February 25, 2013 and is designated Class II. 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… The recall status is terminated (terminated October 23, 2013). Affected quantity: 132,301 units total.

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