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 roche-diagnostics.us and roche.
All trademarks used or mentioned in this release are legally protected
by law.
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.
Roche Diagnostics
roche
View drug information on Warfarin Sodium tablets.
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