Devices

Device Recall CoaguChek XS System (HCP)

Model / Serial
Model/Catalog/Part Number: 04837975001 and 04625412160
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
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.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
- Recall of Device Recall CoaguChek XS System (HCP)

Manufacturer

Roche Diagnostics Operations, Inc.

Manufacturer Address
Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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