Roche Diagnostics Recalls CoaguChek PT Test Strips

In October 2006, Roche Diagnostics recalled all of the company's CoaguChek® PT test strips because a possible defect in the test strips may cause falsely elevated test results. These strips are used in clinical settings and by patients at home to monitor anticoagulation therapy.

Although only a small percentage of the test strips may be affected by this problem, falsely high INR results could cause the patient to receive the wrong dose of anti-coagulant or unnecessary corrective measures to reduce the effect of circulating anti-coagulants. Both of these incorrect treatments could put patients at risk for blood clots.

The company is working on a permanent fix for this problem. In the meantime, Roche Diagnostics is notifying home users and healthcare professionals about this problem. Patients who use these products in their homes should take the following steps: immediately stop using these strips, discard any unused product and consult their health care professional about alternate testing options.

Health care professionals may continue to use these strips in their facilities, but to reduce the chance for inaccurate results, they should conduct duplicate testing on their patients using CoaguChek PT test strips from two different lot numbers. Patients and health care professionals who have questions can call Roche Diagnostics at 1-800-820-0995.

Category:

News & Politics

Tags:

• CoaguChek
• PT
• Test
• Strips
• Anticoagulation
• Blood
• Clots
• Patient
• Safety