Urgent Medical Device Recall:
ONETOUCH SURESTEP Test Strips

To find out if your test strips are affected, call LifeScan Customer Service
in your country. Go to the country selector on the top right of this page and select your country to
find out the local contact details and operating hours.

 

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Urgent Medical Device Notice
Consumer, Retailer and GP Notification letter
Hospital Notification letter

Consumer, Retailer and GP Notification letter

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 the following 9 lots of ONETOUCH SURESTEP Test Strips because they may provide low test results when your blood glucose is greater than 400 mg/dL/22.2 mmol/L.

Recalled Lot Size Description Recalled Lot Size Description
# 2986876 25-ct ONETOUCH SURESTEP # 2982532 50-ct ONETOUCH SURESTEP
# 2988275 50-ct ONETOUCH SURESTEP # 2969290 50-ct ONETOUCH SURESTEP
# 2969252 50-ct ONETOUCH SURESTEP # 2969479 25-ct ONETOUCH SURESTEP
# 2990648 50-ct ONETOUCH SURESTEP # 2991519 10-ct ONETOUCH SURESTEP
# 2966727 50-ct ONETOUCH SURESTEP      

If you receive a meter reading that is greater than 400 mg/dL /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, 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

  1. To find out if your test strips are affected, contact LifeScan Customer Service in your country for any return and replacement of affected product as needed. (Go to the country selector on the top right of this page and select your country to find out the local contact details and operating hours.)
  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 400 mg/dL/22.2 mmol/L 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.

 

Sincerely,

LifeScan Customer Service

   
 

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