Archived - For the Public - Association of Confirm® Clearly Smart Pregnancy Test and Refills with false-positive results

Starting date:

February 27, 2007

Posting date:

March 6, 2007

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000526

This is duplicated text of a letter from Durex Canada, Division of SSL Canada Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication

Health Canada Endorsed Important Safety Information on Confirm^® Clearly Smart Pregnancy Test

Durex Canada, Division of SSL Canada Inc.

February 27, 2007

Subject: Association of Confirm^® Clearly Smart Pregnancy Test and Refills with false-positive results

• Durex Canada, Division of SSL Canada Inc. is conducting a recall of the Confirm^® Clearly Smart Pregnancy Test (Confirm^® Clearly Starter Kits and Confirm^® Clearly Refills) due to a higher than expected rate of consumer complaints reporting false-positive and "inconsistent" results. There have been a number of cases where the Confirm^® Clearly Smart Pregnancy Test confirmed pregnancy when the woman was not in fact pregnant. These women then either had their menstrual period, or saw their doctor, who determined that the woman was not pregnant.
• The Confirm^® Clearly Smart Pregnancy Test works by detecting the hormone human chorionic gonadotropin (hCG) in the urine that the body produces during pregnancy. In addition to defects that may be causing the Confirm^® Clearly Smart Pregnancy Test to sometimes yield inaccurate results, certain drugs, as well as rare medical conditions can also cause inaccurate results. It is therefore very important that any woman suspecting a pregnancy consult with her doctor to confirm the pregnancy and initiate the appropriate prenatal care, if necessary, as soon as possible. It is not expected that these defects are likely to cause serious adverse health consequences.
• The Confirm^® Clearly Smart Pregnancy Test is not intended to replace a doctor's diagnosis.

All distribution of the Confirm^® Clearly Smart Pregnancy Test and Confirm^® Clearly Refills has been suspended, and this product is being removed from the retail market. Any Canadian consumer or retailer with unused product may return this product to the following address:

Durex Canada

Division of SSL Canada Inc.

100 Courtland Avenue

Concord, Ontario

L4K 3T6

A refund will be issued for any unused product with proof of purchase and the associated shipping costs incurred. For questions on product returns and reimbursement, please contact Durex Canada toll-free at 1-800-851-0443, by fax at (905) 669-9662, or send us a message through our website at www.confirmclearly.com.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using Confirm^® Clearly Smart Pregnancy Test should be reported to Durex Canada, Division of SSL Canada Inc. or Health Canada at the following addresses:

Durex Canada (Division of SSL Canada Inc.)

100 Courtland Avenue

Concord, Ontario L4K 3T6

Tel: 1-800-851-0443

Fax: (905) 669-9662

or through the Confirm^® Clearly Smart Pregnancy Test website at www.confirmclearly.com.

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 the 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

John C. Fanaras

Regulatory Consultant

Durex Canada, Division of SSL Canada Inc.