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Recall Observatory FDA recall evidence

Device product

LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.

Z-1130-2013

February 25, 2013

Class II

Product summary

Firm
Lifescan Inc
Event
Event 64478
Status
Terminated
Classification
Class II
Quantity
132,301 units total
Official record key
device-enforcement:Z-1130-2013

Official wording

Reason: 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.

Code information: 2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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