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 debuts iOS app for blood coagulation test device

Roche unveiled a new app for patients on anticoagulation therapy, allowing them to see results from their at-home blood clotting tests on an iOS device. The app connects via Bluetooth to the CoaguChek ...
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 ...
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 ...
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 ...
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, ...