Devices

Device Recall Siemens Coagulation FIX Deficient PlasmaClotting Factor VIIIIXXIXII Deficient Plasma

Model / Serial
10454742 10454729 10461894 10470625
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- Austria, Bulgaria, Belgium, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Italy, Latvia, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia, Bahrain, Belarus, Bosnia-Herzegovina, Guadeloupe, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Qatar, Russia, San Marino, Saudi Arabia, Serbia, South Africa, United Arab Emirates, Argentina, Brazil, Chile, El Salvador, Peru, China, Mexico, Canada and United States.
Product Description
Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. || In vitro diagnostic reagent for the determination of the activity of coagulation factor IX in human plasma by coagulometric methods.
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall Siemens Coagulation FIX Deficient PlasmaClotting Factor VIIIIXXIXII Deficient Plasma

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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