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eMedAlert
OneTouch Ultra Control Solution
 

 February 25, 2013                                                                 Urgent Medical Device Recall

                                                                                    OneTouch® Ultra® Control Solution

 

 

Dear Valued Customer:

 

 

This letter is to inform you that LifeScan is voluntarily removing and replacing five lots of OneTouch® Ultra® Control Solution distributed in the United States. The purpose of Control Solution Testing is to confirm that the meter and test strips are working together correctly as a system.  The five lots of control solution are being replaced because they may not provide an “in range” control test result when used with OneTouch® Ultra® Test Strips, even though your system is working correctly.  As your meter’s User Guide and Control Solution instructions for use state, an out of range Control Solution test result may mean the meter system is not working properly. This may lead to a delay in further blood sugar testing until the issue is resolved.

 

This Issue Applies To Control Solution Test Results Only. The accuracy of patient blood sugar test results is not affected.     

 

What you Should Do

1.  Please check your OneTouch® Ultra® Control Solution to find out if it is from any of the five lots listed below that are subject to replacement.  The lot number can be found on the outside of the Control Solution Carton and on the Control Solution Bottle Label. 

 

Impacted OneTouch® Ultra® Control Solution*

 

Lot #

Expiration Date

Lot #

Expiration Date

2AA2G01

7-31-2014

2AA2G02

7-31-2014

2AA2G03

8-31-2014

3AA2G04

12-31-2014

3AA2G05

12-31-2014

 

  *These products were distributed only in the United States.

 

 

2.  If you have any OneTouch® Ultra® Control Solution from these lots,

     you should discontinue its use immediately and call OneTouch® Customer Service at              866-461-0043 to request replacement product free of charge. 

 

3.  If you have control solution from the lots listed in this letter, you may continue to use your blood glucose system while waiting for your replacement control solution.  However, you should discontinue using your system and call LifeScan for assistance if you: suspect that the meter and strips are not working properly; have repeated unexpected glucose results; or drop or damage the meter.

 

If you ever experience symptoms that are not consistent with your blood glucose results, call your health care professional. Never ignore symptoms or make significant changes to your diabetes management program without speaking to your health care professional.

 

If you have any questions about this notice, please call OneTouch® Customer Service Line at 866-461-0043.