Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1581-2013)

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 (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.

Product Classification:

Class II

Date Initiated: May 16, 2013

Date Posted: July 3, 2013

Recall Number: Z-1581-2013

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: 204,205 meters total

Code Information:

Model/Catalog/Part Number: 04837738001

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated