LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Downl
FDA device recall Z-1317-2008 · posted 2008-04-08 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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.
- Date initiated
- 2007-12-18
- Date posted
- 2008-04-08
- Date terminated
- 2008-07-18
- Location
- Milpitas, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IN TOUCH DIABETES MANAGEMENT SOFTWARE (K984527) | Lifescan, Inc. | 1999-04-29 |