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For the Public - Recall of certain lots of SureStep Blood Glucose Meters
- Starting date:
- April 13, 2006
- Posting date:
- June 22, 2006
- Type of communication:
- Public Communication
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Audience:
- General Public
- Identification number:
- RA-19000471
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from LifeScan Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.
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(PDF Version - 653 K)
Contact : MHPD DPSC
Notice about Health Canada advisories
Public Communication - Health Canada Endorsed Important Safety Information on the recall of certain lots of SureStep Blood Glucose Meters
April 13, 2006
Subject: URGENT: MEDICAL DEVICE RECALL - OneTouch® SureStep® Meters with Serial Numbers from L 3152 Rx xxxxx to L 5348 Rx xxxxx Require Replacement
Dear LifeScan Customer:
LifeScan is replacing specific OneTouch® SureStep® Meters due to a possible issue with the meter's display. If you use a OneTouch SureStep Blood Glucose Meter, please read the following important information so that you can determine if your meter is affected and how to receive an appropriate replacement meter at no charge.
Certain OneTouch SureStep Meters are More Likely to Develop Display Problems
The OneTouch SureStep Meter has a display that shows test results and other important information. This display is made up of "segments" that are turned on and off to form letters and numbers.
Over time, the segments in any Liquid Crystal Display (LCD) can fail. For this reason, all OneTouch SureStep Meters have a built-in display check and come with an owner's booklet that contains instructions on how to check the display when turning the meter on.
Recently, LifeScan has found that segments in the displays of certain OneTouch SureStep Meters may fail at a rate that is higher than expected. This failure 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.
What You Should Do
- Check your meter's serial number.
- Call LifeScan if your meter's serial number is in the affected range.
- If your meter is not in the affected range, please be sure to check the display before each test.
1. Check your meter's serial number
OneTouch SureStep Meters with serial numbers from L 3152 Rx xxxxx to L 5348 Rx xxxxx are more likely to have a problem with segments in the display. Please check the serial number on the back of your meter immediately to find out if it is in this range. (See Figure 1 on how to check the serial number.) You can also call the OneTouch SureStep Meter Replacement Line at 1 866 296-9138 to find out if your meter is affected.
Figure 1
2. Call LifeScan if your meter's serial number is in the affected range
LifeScan will replace all OneTouch SureStep Meters with serial numbers from L 3152 Rx xxxxx to L 5348 Rx xxxxx. If you have a OneTouch SureStep Meter with a serial number in this range, please call the Meter Replacement Line at 1 866 296-9138 to receive a replacement meter. Please have your meter with you when you call.
Until your replacement meter arrives, you should continue to use your current meter, as long as the display is working properly.
3. Check your meter's display before every test
It is very important that you check the display before each test. (See the instructions below.) If you ever find that the display is not working properly, do not use the meter and call the Meter Replacement Line at 1 866 296-9138 for assistance.
How To Check Your OneTouch SureStep Meter's Display
To check that all display symbols are working, press and release the blue power button. The whole display will appear for 3 seconds 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 Figure 2 below). A similar picture of a properly working display test can also be found in your OneTouch SureStep Meter Owner's Booklet.
Figure 2
Keep This Letter and Be Sure To Contact LifeScan
Again, if you have a OneTouch SureStep Meter with serial numbers from L 3152 Rx xxxxx to L 5348 Rx xxxxx, please call the Meter Replacement Line at 1 866 296-9138 to receive a replacement meter at no charge. We recommend that you keep this letter with your OneTouch SureStep Meter as a reference so that you can check your meter's display before each test.
LifeScan Canada Ltd.
#300-4170 Still Creek Drive,
Burnaby, B.C. V5C 6C6
Tel: 1 866 296-9138 (Mon. -Fri., 9:00 am to 8:00 pm EST)
www.OneTouch.ca
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: (613) 954-6522
Fax: (613) 952-7738
We apologize for any inconvenience this issue may cause, and we thank you for your continued support of LifeScan.
Sincerely,
original signed by
Les Klajnscek
President
LifeScan Canada Ltd.
P.S - If you no longer own a OneTouch SureStep Meter, please call us at 1 866 296-9138 to update your record for this notification.
Trademarks owned by Johnson & Johnson and used under license.
®2006 LifeScan Canada Ltd. AW 086-498
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