Devices

Device Recall ADVIA Centaur TnIUltra Assay

Model / Serial
All lots. 500 tests: Part/Catalog #02790309, and 100 tests: Part/Catalog # 02789602.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA, Argentina, Austria, Australia, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Malaysia, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela
Product Description
ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591
Manufacturer
Siemens Medical Solutions Diagnostics
1 Event
- Recall of Device Recall ADVIA Centaur TnIUltra Assay

Manufacturer

Siemens Medical Solutions Diagnostics

Manufacturer Address
Siemens Medical Solutions Diagnostics, 511 Benedict Avenue, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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