October 20, 2006

Subject: FDA - MedWatch - CoaguChek PT Test Strips Nationwide Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Roche Diagnostics and FDA informed consumers and healthcare professionals of the recall of CoaguChek PT test strips used to determine blood clotting time of patients taking anti-coagulant medication to prevent blood clots. The recall was due to the potential for a test strip defect that may cause falsely elevated test results, resulting in an incorrect dose of anti-coagulant medication or unnecessary corrective measures being taken to reduce the effect of circulating anti-coagulants. Healthcare professionals who use CoaguChek PT test strips should institute 'duplicate testing', or use two strips with different lot numbers, on each patient to reduce the risk of bias.
Home users of CoaguChek PT test strip should immediately discontinue use of the product and contact their healthcare provider.

Read the complete MedWatch 2006 safety summary, including a link to the FDA press release at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#CoaguChek