Urgent Medical Device Recall: OneTouch® SureStep® Test Strips - February 24, 2010 |
Dear OneTouch® Customer:
We are immediately recalling specific lots of OneTouch® SureStep® Test Strips because they may provide low test results when your blood glucose is greater than 22.2 mmol/L. If you receive a meter reading that is greater than 22.2 mmol/L with these test strips, it is important that you confirm this result by another means because your actual blood glucose may be significantly higher. For example, if your blood glucose is greater than 22.2 mmol/L, retest your blood glucose using a meter other than OneTouch® SureStep® or contact your healthcare professional for further instructions.
Contact LifeScan Immediately To Find Out If Your Test Strips Are Affected
1. To find out if your OneTouch® SureStep® Test Strips are affected, please call the OneTouch® Customer Care Line at 1-866-339-3045, Monday to Friday, 6:00am-5:00pm PT (9:00am-8:00pm ET). Replacement product will be shipped to you immediately.
2. While you wait for your replacement product to arrive, you should continue to test your blood glucose. However, if you use these affected strips and receive a result of 22.2 mmol/L or higher, there is a possibility that your blood glucose is significantly higher and you should confirm this result via another means or contact your healthcare professional.
We apologize for any inconvenience this issue may cause and have already taken steps to prevent it from recurring in the future. Thank you for your continued support of OneTouch®.
OneTouch® SureStep® Consumer Test Strips Will Be Discontinued in Canada
Please note that OneTouch® will discontinue the manufacture of OneTouch® SureStep® Consumer Test Strips effective immediately in Canada. The OneTouch® SureStep® Meter has not been available in Pharmacy since 2006, and will no longer be supported as of April 30, 2010.
OneTouch® is committed to providing patients the support they need, and is offering a free upgrade to replace your existing meter and test strips before April 30, 2010.
If you are using a OneTouch® SureStep® Meter, please call us immediately to find out if your test strips are affected and to receive your free upgrade. Please call the OneTouch® Customer Care Line at 1-866-339-3045, Monday to Friday, 6:00am-5:00pm PT (9:00am-8:00pm ET). Replacement product, including test strips, will be shipped to you immediately.
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