FDAFDA · Food and drugs·Recall number Z-1129-2013
LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
Published April 24, 2013 · Recall initiated: February 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lifescan Inc
- Distributor
- 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.
- Lot
- 2AA2G01, Exp. Date: 7-31-2014; 2AA2G02, Exp. Date: 7-31-2014; 2AA2G03, Exp. Date: 8-31-2014; 3AA2G04, Exp. Date: 12-31-2014; 3AA2G05, Exp. Date: 12-31-2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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