Roche Diagnostics Operations, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1582-2013)

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 Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).

Product Classification:

Class II

Date Initiated: May 16, 2013

Date Posted: July 3, 2013

Recall Number: Z-1582-2013

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: 537 meters total

Code Information:

Model/Catalog/Part Number: 05530199160

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated