Recall Z-1317-2008 ยท NBW System, Test, Blood Glucose, Over The Counter
Lifescan Inc
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
| Date | Apr 8, 2008 (initiated Dec 18, 2007) |
| Status | Terminated |
| Reason | Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily. |
| Root cause | Software design |
| Action | The firm sent an Urgent Recall letter to Health Care Professionals on 12/18/2007. The letter advised user to uninstall software drivers and provided options on how to uninstall. For further assistance, please contact LifeScan Customer Service at 1-866-679-9250. |
| Quantity | 260 units |
| Distribution | Nationwide Distribution including the states of AL, CA, IN, IO, MA, MD, MI, MS, NE, NY, NC, OR, PA, TN, TX, UT, VT, VA, WV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984527 | IN TOUCH DIABETES MANAGEMENT SOFTWARE Lifescan, Inc., Apr 29, 1999 |