Recall Z-1129-2013 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Lifescan Inc
LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels.
| Date | Apr 17, 2013 (initiated Feb 25, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| 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 th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062195 | MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., Aug 16, 2006 |