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Urgent Medical Device Recall: Replace OneTouch® SureStep® Meters

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Recall Expanded to Include Meters with Serial Numbers between L3152Rxxxxxx and L5348Rxxxxxx

April 14, 2006

LifeScan, Inc. is replacing specific OneTouch® SureStep® Meters due to a possible issue with the meter's display. This is an expansion of the number of specific meters that LifeScan will replace as first identified in the September 2005 letter informing affected users of the issue.

If you use, recommend, distribute or sell the OneTouch SureStep Blood Glucose Meter, please read and understand this important information so that you can determine if your meter is affected and how to receive an appropriate replacement meter at no charge.

Certain OneTouch SureStep Meters Are More Likely To Develop Display Problems
The OneTouch SureStep Meter has a display that shows test results and other important information. This display is made up of "segments" that are turned on and off to form letters and numbers.

Over time, the segments in any Liquid Crystal Display (LCD) can fail. For this reason, all OneTouch SureStep Meters have a built-in display check and come with an owner's booklet that contains instructions on how to check the display when turning the meter on.

Recently, LifeScan has found that segments in the displays of certain OneTouch SureStep Meters may fail at a rate that is higher than expected. This failure can cause certain letters or numbers in the display to appear incomplete or missing. If the display is failing, it is possible that it will show a test result or a calibration code that you could misinterpret or that you can't read at all.

What You Should Do
1. Check your OneTouch SureStep Meter's serial number.
2. Call LifeScan if your meter's serial number is in the affected range.
3. If your meter is not in the affected range, please continue to check the display before each test.

1. Check your meter's serial number
OneTouch SureStep Meters with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx are more likely to have a problem with segments in the display. Please check the serial number on the back of your meter immediately to find out if it is in this range. (See Figure 1 to check the serial number.) You can also call LifeScan Customer Service for 24-hour assistance to find out if your meter is affected.

How to check the serial number on the back of the OneTouch SureStep Meter

Serial Number in circled area
(example)>

OneTouch SureStep Meter
 

2. Call LifeScan if your meter's serial number is in the affected range
LifeScan will replace all OneTouch SureStep Meters with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx. If you have a OneTouch SureStep Meter with a serial number in this range, please call the LifeScan Customer Service Line immediately (24 hours a day) to receive a replacement meter. While we will not be able to provide you with another OneTouch SureStep Meter, we will make arrangements with you to have an appropriate replacement meter sent to you at no charge. Until your replacement meter arrives, you should continue to use your current meter, as long as the display is working properly.

3. Check your OneTouch SureStep Meter's display before every test
It is very important that you check the display before each test (see instructions). If you ever find that the display is not working properly, do not use the meter and call LifeScan Customer Service immediately for 24-hour assistance.

How To Check Your OneTouch SureStep Meter's Display
To check that all display symbols are working, press and release the blue power button. The whole display will appear for three seconds when you turn on the meter. You should carefully look at the display to make sure all "segments," or parts of the display, turn on before each test (see Figure 2). A picture of a properly working display test can also be found in your OneTouch SureStep Meter Owner's Booklet.

DISPLAY TEST
Properly Functioning Display Display

Properly Functioning Display Display

All segments are active. Display is working properly.

DISPLAY TEST EXAMPLE
Display Display with Missing Segments

Display Display with Missing Segments

Some parts of the display are not working. Message is incomplete.

TEST RESULT EXAMPLE
Recognizable Result, but Incorrect

Recognizable Result, but Incorrect

In this example, the 120 result is really 420, as shown by the missing segments in gray.

 

Keep This Letter and Be Sure To Contact LifeScan
Again, if you have a OneTouch SureStep Meter with serial numbers between
L3152Rxxxxxx and L5348Rxxxxxx
, please call the LifeScan Customer Service Line to receive a replacement meter at no charge. We recommend that you print this notice and keep it with your OneTouch SureStep Meter as a reference so that you can check your meter's display before each test. If you have any questions about this issue, please contact LifeScan Customer Service.

How To Contact LifeScan

People with diabetes
Telephone: U.S. 866 679-9248, For all other countries, see Around the World.

E-mail: CustomerService@LifeScan.com

Healthcare Professionals
Telephone: U.S. 800 951-7616, For all other countries, see Around the World.

Pharmacists
Telephone: U.S. 800 951-7617, For all other countries, see Around the World.

Hospitals and Other Inpatient Health Care Facilities
Telephone: U.S. 866 786-7537, For all other countries, see Around the World.

Distributors
Telephone: U.S. 888 845-8904, For all other countries, see Around the World.

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