Recall Z-1317-2008
Lifescan Inc · initiated December 18, 2007
Product
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.
Codes / lots: Part Number: 021-722-01
Reason for recall
Meter Temporarily Freezes-- A software compatibility issue may cause the blood glucose meter to cease operations and freeze temporarily.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-1317-2008
- Initiated
- December 18, 2007
- Posted by FDA
- April 8, 2008
- Terminated
- July 18, 2008
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- 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.
- Recalling firm
- Lifescan Inc, Milpitas, CA