TP-01142
page 5 of 5
Actions to be Taken by Roche _____________________________________________
Labeling changes will be made to the CoaguChek® XS PT Test 6 count (catalog number
04625374160) package insert and the CoaguChek XS User Manual for Patient Self Testing
(literature number 04999045001) to:
• provide awareness of measuring unit settings
• ensure that the measuring unit result is set to INR
• provide instructions for resetting to INR units
Questions _______________________________________________________________
Please contact the Roche Customer Support Center, Monday through Friday 7:00 a.m. to
11:00 p.m. EST, at 1-800-428-4674 if you have questions about the information contained in
this UMDC.
This UMDC is being conducted with the knowledge of the U.S. Food and Drug Administration
(FDA).
Adverse events or quality problems experienced with the use of this product may also be
reported to the FDA’s MedWatch Adverse Events Reporting Program: Online at
http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form is available to fax or
mail), or call FDA 1-800-FDA-1088.
COAGUCHEK and COAGUCHEK VANTUS are trademarks of Roche.
