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 ...

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 ...

The CoaguChek XS system (Roche Diagnostics) comprises a meter and specifically designed test strips that can analyse a blood sample (fresh capillary blood or fresh untreated whole venous blood) and ...

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 ...

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 ...

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 ...

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 ...

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, ...

This notification supplements previous Urgent Medical Device Correction (UMDC) communications initially issued by Roche Diagnostics on September 12, 2018 and updated on October 17, 2018. Roche ...

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 ...