FDAFDA · Food and drugs·Recall number Z-1583-2013
CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
Published July 3, 2013 · Recall initiated: May 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Model/Catalog/Part Number: 05021537001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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