Z-1584-2013 Class II Terminated
FDA device recall Z-1584-2013 was initiated by Roche Diagnostics Operations, Inc. on May 16, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 16, 2014). Affected quantity: 86553 meters.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 3, 2013
- Initiation Date
- May 16, 2013
- Termination Date
- Apr 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 86553 meters
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.
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.
Distribution Pattern
Nationwide Distribution
Code Information
Model/Catalog/Part Number: 04837975001 and 04625412160
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1584-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026