National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

The National Institute for Health and Care Excellence (NICE) is producing guidance on using the CoaguChek XS system and the INRatio2 PT/INR monitor in the NHS in England. The Diagnostics Advisory ...
News Medical

Roche receives FDA 510(k) clearance for CoaguChek XS Pro point-of-care anticoagulation monitor

Roche Diagnostics announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CoaguChek® XS Pro system, a new point-of-care anticoagulation monitor with a ...
Medindia

New Handheld Base Unit for CoaguChek XS Plus System Enables Connectivity to RALS-Plus Data Management Solution for PT/INR Testing at the Point of Care

INDIANAPOLIS, Nov. 11 The U.S. Food and DrugAdministration has granted approval for the new Handheld Base Unit for theCoaguChek(R) XS Plus System, which provides connectivity between ...
FiercePharma

FDA grants CLIA-waived status to CoaguChek XS Plus system for PT/INR testing at the point of care

Exemption of the system from virtually all CLIA rules gives more labs access to connectivity and data management capabilities for monitoring patients on warfarin therapy INDIANAPOLIS, Oct. 1, 2012 ...
News Medical

Roche Diagnostics' CoaguChek XS Plus system granted CLIA-waived status

Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted CLIA-waived status to the CoaguChek® XS Plus system, a point-of-care anticoagulation monitor that offers ...
FierceBiotech

Medicare Announces Expanded Coverage for Warfarin Patients Monitoring Clotting Time at Home

INDIANAPOLIS, March 19 /PRNewswire/ -- Medicare Part B will now cover and pay for meter training, equipment and supplies for all long-term warfarin users who monitor their prothrombin time at home ...
Monthly Prescribing Reference

FDA: Class I Recall of Test Strips Due to Inaccurate INR Results

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled. Roche Diagnostics has issued a recall of certain lots of CoaguChek XS PT Test Strips, ...
TCTMD

More INR Test Strips Recalled Due to Inaccurately High Results

A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings. Roche Diagnostics ...
Pharmabiz

US FDA clears Roche's CoaguChek XS Pro system with bar code reader for PT/INR testing at the point of care

Roche Diagnostics announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the CoaguChek XS Pro system, a new point-of-care anticoagulation monitor with a ...
TCTMD

INR Test Strips Recalled Due to Inaccurate Measurements

Roche Diagnostics has recalled more than 1.1 million packages of its CoaguChek XS PT test strips, which are used for monitoring international normalized ratio (INR) in patients taking warfarin. The US ...
National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

Point-of-care coagulometers (the CoaguChek XS system and the INRatio2 PT/INR monitor) for self-monitoring coagulation status in people on long-term vitamin K antagonist therapy who have atrial ...