Indianapolis, Ind. September 26, 2003

Nationwide recall notice on medical device used to determine blood clotting time

Roche Diagnostics is notifying users of an important recall of all CoaguChek PT test strips currently in the market place because of the potential for a packaging defect that will cause false results.

CoaguChek PT test strips are used by patients in the home and by professionals in medical settings to determine blood clotting time of patients taking anti-coagulants, also known as blood thinners, and to diagnose some disease conditions. Incorrect results may have serious or life threatening consequences because patients may be improperly diagnosed or improperly treated. Blood thinners are used to treat patients with a potential for blood clots. For example, patients with heart valve replacement, certain types of heart disease or blood clots in their legs.

Roche has determined that some of the foil pouches in which the test strips are packaged were improperly sealed allowing moisture and air to enter the pouch. These products give false results when exposed to moisture for more than a few minutes. Home users should contact their health care professional for further advice and instructions.

Roche Diagnostics is notifying all home users and health care professionals who use the product to inspect the foil pouch prior to use and to perform duplicate testing for all lots until further notice. The problem is the perforation and the "easy open" notches are not properly centered between the pouches. Users must inspect each pouch prior to use, not use any strips from that box if they see a defect, and run two test strips each time they test in case they fail to visually detect the defect.

Investigations reveal that only a small percentage of the strips are affected. There have been no reports of illnesses or injuries resulting from a pouch defect.

Letters are being sent to customers, providers, and physicians, informing them of this voluntary action. Additional information, including a photograph of the defective pouch, will be posted on Roche Diagnostics' U.S. CoaguChek Web site at: http://www.coaguchek-usa.com.

US customers with immediate concerns, or interested in details of this recall, can call Roche Diagnostics Point of Care Technical Service at: 1-800-428-4674.

Roche Diagnostics has implemented corrective actions to resolve this issue. This action is being taken by Roche Diagnostics with the knowledge of the U.S. Food and Drug Administration.