Archived - Important Safety Information on BD Logic, BD Latitude and The Link Blood Glucose Monitors - Becton, Dickinson and Company

Starting date:

January 1, 2006

Posting date:

January 1, 2006

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000431

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Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Safety Information on BD Logic^®, BD Latitude^T, and The Link^® Blood Glucose Monitors

January 2006

Subject: URGENT: MEDICAL DEVICE CORRECTION BD Logic^®, BD Latitude^T, The Link^® Blood Glucose Monitors

Dear Valued Customer,

Our records indicate that you may be using BD Logic^®, BD Latitude^™ or The Link^® Blood Glucose Monitors. To ensure that you continue to obtain accurate blood glucose test results, we ask that you review the following important information. If you currently do not use these monitors please disregard this letter.

In Canada, the monitors identified above are programmed to display test results in "mmol/L" and cannot be changed by the user. On very rare occasions these monitors may switch the blood glucose test result display from "mmol/L" to "mg/dL".This might happen during an event such as installing a battery or dropping the monitor.

If your monitor displays the blood glucose test result in "mg/dL", you may misunderstand your test result. This misunderstanding could lead you to manage your diet or medication in a way that could cause temporary periods of low blood glucose.

Please continue to use your monitor to test your blood glucose. Each time that you test, you should confirm that the test results are correctly displayed as "mmol/L" (see the attached insert). If your monitor displays a result in "mg/dL", do not use this test result and call BD for assistance, at 1-866-556-8123 (not for medical or emergency use) toll free, 24 hours a day, 7 days a week. If your monitor correctly displays results in "mmol/L", there is no need to contact BD and you can continue to use your monitor.

This notification does not affect BD^™ Test Strips. For quick reference, see the enclosed insert: "Check Every Time You Test".

We apologize for any inconvenience this may cause and thank you for your continued support of BD products. If you have questions or concerns, please call BD at 1-866-556-8123 (not for medical or emergency use).

BD

c/o 101 Mary Street W. Suite 300

Whitby, Ontario, L1N 2R4

Product Notification Group

1-866-556-8123

Any suspected adverse reaction 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 AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

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

Tel: (613) 954-6522

Fax: (613) 952-7738

Sincerely,

original signed by

Troy Hopps

Business Director

BD Medical - Diabetes Care

BD, BD Logo, BD Logic, BD Latitude and The Link are trademarks of Becton, Dickinson and Company. ©2006 BD.

PC188

Becton, Dickinson and Company.

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