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Devices
Device Recall CoaguChek XS System (PST)
Model / Serial
Model/Catalog/Part Number: 04837738001
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
CoaguChek XS System (PST) || The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
Manufacturer
Roche Diagnostics Operations, Inc.
1 Event
Recall of Device Recall CoaguChek XS System (PST)
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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
Language
English
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