Business Insider

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

SILVER SPRING, Md., Feb. 1, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the ...
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 ...
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 ...
Medindia

Roche Receives FDA Clearance for CoaguChek XS Pro system With Bar Code Reader for PT/INR Testing at the Point of Care

INDIANAPOLIS, July 26 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 ...
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, ...
Medindia

FDA grants CLIA-waived Status to CoaguChek XS Plus System for PT/INR Testing at the Point of Care

INDIANAPOLIS, March 30 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 ...
Monthly Prescribing Reference

FDA: Unauthorized INR Test Strips Part of Large Recall

Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US. The Food and Drug ...
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 ...
FierceBiotech

Roche Introduces CoaguChek Link Web Resource to Streamline Anticoagulation Management for Doctors and Patients

Secure online application developed in conjunction with Voluntis helps simplify patient management for physicians and reporting of test results for patients who self-test PT/INR INDIANAPOLIS, Nov. 8, ...
Pharmabiz

US FDA warns about risk of inaccurate results from CoaguChek test to monitor blood thinner warfarin

The US Food and Drug Administration (FDA) has warned patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips ...
Medscape

Distributor Recalls All Its Roche CoaguChek Anticoagulation Test Strips

Terrific Care/Medex Supply has announced a recall of all test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters that it has distributed for direct consumer ...
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)

During the development of this resource, NICE worked with the manufacturer to identify NHS organisations using CoaguChek XS for self-monitoring. These organisations agreed to provide structured ...