URGENT: MEDICAL DEVICE RECALL
OneTouch® GlucoTouch® Meters To Be Replaced
Recall Expanded to Include Meters with Serial Numbers between L3152R and L5348R
May, 2006
LifeScan, Inc. is replacing specific OneTouch® GlucoTouch® Meters due to a possible issue with the meter's display.
If you use, recommend, distribute or sell the OneTouch GlucoTouch 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 GlucoTouch Meters Are More Likely To Develop Display Problems
The OneTouch GlucoTouch 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 GlucoTouch 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 GlucoTouch 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 GlucoTouch 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 GlucoTouch Meters with serial numbers between L3152R and L5348R 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 assistance to find out if your meter is affected on 0800 121200 (UK) or 1800 535676 (Ireland), 8.30am-6pm Monday-Friday, 9am-1pm Saturday.
How to check the serial number on the back of the OneTouch GlucoTouch Meter
Serial Number in circled area  (example) |
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2. Call LifeScan if your meter's serial number is in the affected range
LifeScan will replace all OneTouch GlucoTouch Meters with serial numbers between L3152R and L5348R. If you have a OneTouch GlucoTouch Meter with a serial number in this range, or if you have trouble finding or reading our meter serial number, please call the LifeScan Customer Service Line immediately to receive a replacement meter. Customer care phonelines 0800 121200 (UK) or 1800 535676 (Ireland), 8.30am-6pm Monday-Friday, 9am-1pm Saturday. While we will not be able to provide you with another OneTouch GlucoTouch 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 GlucoTouch 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 assistance.
How To Check Your OneTouch GlucoTouch 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 GlucoTouch Meter Owner's Booklet.
DISPLAY TEST
Properly Functioning Display |
DISPLAY TEST EXAMPLE
Display with Missing Segments |
TEST RESULT EXAMPLE
Recognizable Result, but Incorrect |
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All segments are active. Display is working properly. |
Some parts of the display are not working. Message is incomplete. |
In this example, the 8.6 result is really 8.8, as shown by the missing segments in gray. |
Figure 2
Keep This Letter and Be Sure To Contact LifeScan
Again, if you have a OneTouch GlucoTouch Meter with serial numbers between L3152R and L5348R 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 GlucoTouch 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
0800 121200 (UK) or 1800 535676 (Ireland), 8.30am-6pm Monday-Friday, 9am-1pm Saturday