Urgent Medical Device Recall: OneTouch® SureStep® Test Strips
To find out if your test strips are affected, call LifeScan Customer Service at +632 824-8736 (GMA), 1-800-1-7954 (Toll Free) between 7:30 a.m to 4:30 p.m, Monday through Friday
Urgent Medical Device Recall
9 Lots of OneTouch® SureStep® Test Strips
24 February 2010
Dear Valued Customer:
At LifeScan we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that does not meet our expected standards.
If you use the OneTouch® SureStep® Test Strips, have patients who use them or distribute the OneTouch® SureStep® Test Strips, please take note of the following information.
We are immediately recalling (Insert of lot(s) affected in each local country) lots of OneTouch® SureStep® Test Strips because they may provide low test results when your blood glucose is greater than 400 mg/dL. If you receive a meter reading that is greater than 400 mg/dL 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, retest your blood glucose using a meter other than SureStep® or contact your healthcare professional for further instructions.
Contact LifeScan Immediately To Find Out If Your Test Strips Are Affected
To find out if your test strips are affected, contact LifeScan Customer Service at +632 824-8736 (GMA), 1-800-1-7954 (Toll Free) between 7:30 - 16:30 Weekdays (Mon - Fri) for any return and replacement of affected product as needed.
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 400 mg/dL or higher from your OneTouch® SureStep® System, 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.
Our first priority is to provide the highest quality products so that you can test with confidence as recommended by your healthcare professional. We apologize for any inconvenience this issue may cause and thank you for your continued support.
