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Roche says resolves CoaguChek reliability issue

Wed May 23, 2007 8:30am EDT

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ZURICH, May 23 (Reuters) - Swiss drugmaker Roche Holding AG (ROG.VX) said on Wednesday it had resolved a reliability concern over its CoaguChek anticoagulation monitoring test strips in the United States.

Roche said the potential for inaccurate test results, which prompted the Food and Drug Administration to issue an alert on CoaguChek, was caused by too little of the thromboplastin active ingredient on selected test strips.

Healthcare professionals no longer have to carry out duplicate tests to confirm results from some CoaguChek strips, Roche said.

"Fully tested and validated changes have been implemented within the manufacturing process to address this concern," Roche said in a statement. "Every test strip is inspected to ensure that it contains the correct amount of thromboplastin before being packaged and shipped."

((Reporting by Sam Cage, editing by Paul Bolding;

Email: zurich.newsroom@reuters.com

Reuters Messaging: sam.cage.reuters.com@reuters.net

Telephone: +41 (0) 44 631 7457)) Keywords: ROCHE COAGUCHEK/

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