Roche Initiates Voluntary Urgent Product Recall of CoaguChek® XS, CoaguChek XS Plus, and CoaguChek XS Pro Meters

Publication Date: 
Thu, 05/16/2013
By: Alere Staff

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an “ERROR 6” message is displayed.

“ERROR 6” messages are generally due to an activation of the system fail-safe mechanisms that are designed to prevent the release of wrong measurement results.

However, patients who are under treatment with Warfarin in combination with antibiotics and/or chemotherapeutics, which could potentially lead to extremely high coagulation times (> 10 INR), may in rare cases receive repeated “ERROR 6” messages instead of an INR value.

For more information please visit http://coaguchek-usa.com/wp-content/uploads/13_099_CCXS_Error_6_UMDC_HCP.pdf