Devices

Device Recall BCS XP System

Model / Serial
All serial numbers
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Hungary, Italy, Kuwait, Latvia, Lebanon, Libya, Macedonia, Mexico, Montenegro, Netherlands, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and Uruguay.
Product Description
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall BCS XP System

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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