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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description LifeScan brand OneTouch® Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Recall Number Z-1130-2013
Classification Class II
Code Info 2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14
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 Detail

Event Id 64478
Product Type Devices
Status Ongoing
Recalling Firm Lifescan Inc
City Milpitas
State CA
Country US
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.