
A Letter To LifeScan Customers:
--Important Information For SureStep® Meter Users--
May 26, 2001
If you use a SureStep® Meter (also sold in some countries under the GlucoTouch® Brand name) to test your blood glucose, recommend it to your patients, or distribute and sell it to customers, please take a few moments to read this important announcement.
SureStep Test Strip vials have a Color Chart on the label that can be used as an additional check that the meter and test strips are working properly.
We have recently determined that, due to a printing error, the Color Charts on some SureStep vial labels are incorrect. Specifically, the incorrect Color Charts have a colored dot for the 350 mg/dL value that is lighter in color than the dot for the 180 mg/dL value. On a correct Color Chart, the 350 mg/dL dot is darker than the 180 mg/dL dot. This printing error appears only on some SureStep Test Strip vials with an expiration date before August 2002.
What SureStep Meter Users Should Do
- Continue to test as usual. Remember, the meter display is the value you should use. The color dot is only a backup check.
- The dots will clearly show if your blood sugar is low or high, although on vials with the printing error, your blood sugar may be higher than indicated by the color dots. DO NOT rely on the color dots, but rely on your meter.
- Contact LifeScan so that you will receive a corrected color chart when it is available.
How LifeScan Is Addressing This Issue We have corrected the printing error that caused this issue and SureStep Test Strip vials with expiration dates of August 2002 and beyond have the correct Color Chart. In addition, a corrective action plan is being implemented in all countries where test strips with incorrect color charts have been sold. In the United States, LifeScan is taking the following actions to address this issue:
- Beginning in mid-June 2001, a correct replacement Color Chart will be mailed to all registered SureStep Meter users for future reference. In the letter, SureStep Meter users will be reminded that the Color Chart is not a replacement for a SureStep Meter test. It is to be used only as an additional check to confirm a meter reading.
- LifeScan will also be sending a notification letter and a supply of stickers with a correct Color Chart to pharmacists, requesting that they place these stickers on all their SureStep Test Strip boxes.
U.S. Residents: The corrective actions listed above will begin in mid-June and will take a few weeks to complete. If you do not receive a correct Color Chart in the mail by July 15, or when you buy SureStep Test Strips, and would like to receive one in the mail, please call our toll free 24-hour Customer Services line at 1 800 611-5336.
SureStep Meter Test Results Are Not Affected Please be assured that the incorrect Color Chart has no impact on the quality or accuracy of SureStep Test Strips or SureStep Meter Test Results. As stated in the SureStep Meter's Owner's Booklet, the Color Chart is NOT a replacement for a SureStep Meter test. It should only be used as an additional check to confirm a meter reading. People with diabetes should continue to use their SureStep Meter and Test Strips with confidence.
Please note that no other LifeScan OneTouch® Meters or Test Strips are affected by this issue.
How To Contact LifeScan At LifeScan we know our customers rely on our products to help them manage their diabetes. It's a responsibility we take very seriously. If you need to contact LifeScan regarding this issue please contact us in one of the following ways:
People with diabetes Telephone: U.S. 800 227-8862; Canada 800 663-5521; Mexico 95 1 800 381-SCAN; for other countries, for other countries, see Around the World.)
E-mail: CustomerService@LifeScan.com
Healthcare Professionals Telephone: U.S. 800 951-7226, for other countries, see Around the World.)
Retailers/Distributors: Telephone: 800 600-7226, for other countries, see Around the World.)
Thank you for your continued support of LifeScan.
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