Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1584-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.

Product Classification:

Class II

Date Initiated: May 16, 2013

Date Posted: July 3, 2013

Recall Number: Z-1584-2013

Event ID: 65246

Reason for Recall:

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.

Status: Terminated

Product Quantity: 86553 meters

Code Information:

Model/Catalog/Part Number: 04837975001 and 04625412160

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated