LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
FDA Recall Z-1130-2013 · Posted 2013-04-17
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Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeJJX
Date Initiated2013-02-25
Date Terminated2013-10-23
Product Quantity132,301 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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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