FDA-Device2016-05-18Class III
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Siemens Healthcare Diagnostics, Inc.
Hazard
The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
Sold states
Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.
Affected count
US: 442 units; Foreign: 3237 units
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers. This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1615-2016Don't want to check this manually?
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