Atellica CI Analyzer. Catalog Numbers: 10947347.
This recall is currently active, issued December 4, 2024. It was issued by Siemens Healthcare Diagnostics, Inc..
- Recall Initiated
- November 4, 2024
- Posted
- December 4, 2024
- Recall Number
- Z-0597-2025
- Quantity
- 559 units
- Firm Location
- Tarrytown, NY
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
UDI-DI Number: 630414229560; Catalog Number: 10947347. Software version 1.28.51
Root Cause
Software design