Z-1582-2013 Class II Terminated
FDA device recall Z-1582-2013 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: 537 meters total.
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
- 537 meters total
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).
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: 05530199160
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1582-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026