Alere announced a voluntary Class 1 recall of the Alere INRatio2 PT/INR Professional Test Strips due to significantly different test results between the Alere INRatio2 PT/INR Professional Test Strips ...

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 ...

Patients taking the oral anticoagulant drug warfarin (Coumadin) or being given heparin injections and their in-office and home healthcare teams should check the brand of their PT/INR test strips and ...

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 ...

Alere has issued a voluntary correction to users of the Alere INRatio and INRatio 2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor ...

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 ...