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.
Reported: July 3, 2013 Initiated: May 16, 2013 #Z-1583-2013
Product Description
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.
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 3343 meters
- Distribution
- Nationwide Distribution
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 3343 meters.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2013. Severity: Moderate. Recall number: Z-1583-2013.
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