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October 20, 2005
A Letter To LifeScan Customers: URGENT: MEDICAL DEVICE RECALL
OneTouch® SureStep® Plus Meter
LifeScan is replacing specific OneTouch® SureStep® Plus Meters due to a possible issue with the meter’s display. If you use, recommend, distribute or sell the OneTouch SureStep Plus Blood Glucose Meter, please read the following important information to determine if you have product subject to recall.
Certain OneTouch SureStep Plus Meters May Develop Display Problems
The OneTouch SureStep Plus Meter has a display that shows test results and other important information. The display is made up of "segments" that are turned on and off to form letters and numbers. Recently, LifeScan found that in certain OneTouch SureStep Plus Meters, these segments may fail at a rate that is higher than expected. This 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.
Over time, the segments in any Liquid Crystal Display (LCD) can fail. These failures usually appear after the meter has been used for long period of time. For this reason, all OneTouch SureStep Plus Meters have a built-in display check and come with instructions to check the display when turning the meter on.
It is very important that you check your meter’s display before testing.
What You Should Do
OneTouch SureStep Plus Meters with serial numbers L4296RB00079 through L4296RB00337 and L5036RB00996 through L5036RB01440 are more likely to have a problem with the segments in the display. Please check your meter’s serial number immediately to find out if it is in this group. You can also call LifeScan Customer Service to find out if your meter is affected.
| LifeScan will replace all affected OneTouch SureStep Plus Meters with serial numbers L4296RB00079 through L4296RB00337 and L5036RB00996 through L5036RB01440. Please call LifeScan Customer Service immediately at 800 11 78888, 210-6875770 and 2310-392301 for assistance if you have questions or need a replacement meter. |
How To Check Your OneTouch SureStep Plus Meter's Display
Until you get your replacement meter, you can still use your current meter, as long as the display is working properly. To check that all display symbols are working, press and hold down the blue power button. The whole display will appear 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 pictures).
Compare the working segments in your meter's display with these pictures. A similar picture of a properly working display test can also be found in your OneTouch SureStep Plus Meter Owner's Booklet.
| DISPLAY TEST |
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DISPLAY TEST EXAMPLE |
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TEST RESULT EXAMPLE |
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Properly Functioning Display |
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Display with Missing Segments |
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Recognizable Result, but Incorrect |
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All segments are active. The display is working properly. |
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Some parts of the display are not working. Message will be incomplete. |
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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
As a reminder, we recommend that you print this notice and keep it with your OneTouch SureStep Plus Meter. If you have any questions about this issue, please contact LifeScan Customer Service.
How To Contact LifeScan
People with diabetes
Contact our Customer Service department at 800 11 78888 , 210-6875770 and 2310-392301, E-mail : service@cscgr.jnj.com
Healthcare Professionals
Contact our Customer Service department at 800 11 78888 , 210-6875770 and 2310-392301, E-mail : service@cscgr.jnj.com
Retailers / Distributors
Contact our Customer Service department at 800 11 78888 , 210-6875770 and 2310-392301, E-mail : service@cscgr.jnj.com
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