Roche Diagnostics Announces Successful Resolution of Urgent Medical Device Correction of CoaguChek PT Test Strips Used in Anticoagulation Monitoring |
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Roche Diagnostics
9115 Hague Rd., P.O. Box 50457
Indianapolis, IN, 46256
USA
Press release date: May 23, 2007
Healthcare professionals no longer need to do duplicate testing for prothrombin time results
INDIANAPOLIS, May 23 / - Roche Diagnostics, in cooperation with the U.S. Food and Drug Administration, announced today that the Urgent Medical Device Correction issued for CoaguChek PT test strips (UMDC 06-266), used in anticoagulation monitoring, has been addressed and duplicate testing is no longer required for CoaguChek PT Test Strips, lot numbers 560A and higher (e.g., 561A, 562A, ...).
The potential for erroneous prothrombin time (PT) test results that prompted the UMDC was a result of insufficient active ingredient (thromboplastin) on selected test strips. Fully tested and validated changes have been implemented within the manufacturing process to address this concern. Every test strip is inspected to ensure that it contains the correct amount of thromboplastin before being packaged and shipped.
All healthcare professionals performing duplicate testing to confirm results can return to a single test using CoaguChek PT Test Strips (only from lot numbers 560A and higher) to monitor patients on warfarin (anticoagulation) therapy. All patients previously performing patient self-testing may now resume monitoring with CoaguChek PT Test Strips (only from lot numbers 560A and higher).
"Patient safety is Roche Diagnostics' first priority. We are now using an innovative detection system, combined with other measures, to improve our test strip manufacturing process," said Randy Pritchard, Director of Product Marketing, Near Patient Testing, Roche Diagnostics. "We are confident that the potential for erroneous results from inadequate levels of thromboplastin has been addressed, and we are pleased to continue providing healthcare professionals with CoaguChek PT Test Strips and other products that meet the highest standards of quality and patient safety."
About CoaguChek products Physicians have been using CoaguChek instruments for PT/INR testing at the point of care (POC) since 1994. Today, in the U.S., four out of five POC PT/INR tests are performed using a CoaguChek system (1). The new CoaguChek XS system represents the third generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics.
About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our websites at www.roche-diagnostics.us and www.roche.com.
Healthcare Professional/Patient Questions: 1-800-820-0995
(1) Third quarter 2006 total market share of projected distributor unit sales of the Point of Care Testing Coagulation Reagents and Kits product class by HPIS Market Intelligence, a division of GHX Global Healthcare Exchange. Total Market includes all market sectors as defined by HPIS: Physician, Long Term Care, Treatment Centers, Clinical Laboratory, Hospital, Home Healthcare and Other/Unspecified. Data on file.
Source: Roche Diagnostics
CONTACT:Media Questions: Lori McLaughlin, Corporate Communications of Roche Diagnostics, +1-317-521-3112, or Cell: +1-317-409-9762
Web site: http://www.roche.com/
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