FDA-Device2024-12-11Class II
Atellica CI Analyzer. Catalog Numbers: 10947347.
Siemens Healthcare Diagnostics, Inc.
Hazard
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.
Affected count
559 units
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Atellica CI Analyzer. Catalog Numbers: 10947347.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2025Don't want to check this manually?
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