Siemens Healthcare recalls Atellica CI Analyzer (catalog 10947347) due to potential false elevated sodium, potassium and chloride test results from incorrect diluent volume display.
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.
Siemens Healthcare is recalling Atellica CI Analyzers with catalog number 10947347 because the device may show remaining diluent volume incorrectly. This could cause blood test results for sodium, potassium, and chloride to appear falsely elevated, potentially affecting medical decisions.
The analyzer may display a higher diluent volume than actually present. When the diluent is empty but the device still shows it as full, sodium, potassium, and chloride test results become falsely elevated. Quality control tests confirm this issue occurs in the device.
Lab technicians and medical professionals using the Atellica CI Analyzer for blood tests are most at risk. Patients receiving test results from this device could be affected if the false elevations lead to incorrect medical decisions.
Check for the catalog number 10947347 on the Atellica CI Analyzer. The device was sold with software version 1.28.51 and UDI-DI number 630414229560.
Verify if the analyzer shows the correct diluent volume by checking the display for accurate percentage remaining.
The Atellica CI Analyzer may display a higher diluent volume than actually present, causing sodium, potassium, and chloride test results to be falsely elevated.
Test results for sodium, potassium, and chloride may appear falsely elevated, potentially leading to incorrect medical decisions.
Look for catalog number 10947347 on the device, which was sold with software version 1.28.51 and UDI-DI number 630414229560.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0597-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0597-2025 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
