Recall Z-1130-2013
Lifescan Inc · initiated February 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing of Blood Glucose Levels.
Codes / lots: 2AA2101, Exp. Date: 9-30-2014; 2AA2102, Exp. Date: 10-31-2-14
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1130-2013
- Initiated
- February 25, 2013
- Posted by FDA
- April 17, 2013
- Terminated
- October 23, 2013
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 132,301 units total
- Distribution
- 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.
- Recalling firm
- Lifescan Inc, Milpitas, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1129-2013 Class II | LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808…When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the… | 02/25/2013Terminated |