Lower riskMedical device recall · FDA · Published November 4, 2024
Siemens Atellica CI Analyzer Recall: False Test Results Risk
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. Read more at govinfonow.com/recall/53580-siemens-atellica-ci-analyzer-recall-false-test-results-risk.
“Siemens Atellica CI Analyzer Recall: False Test Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53580-siemens-atellica-ci-analyzer-recall-false-test-results-risk. Based on FDA recall #Z-0597-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2025%22&limit=1).
The FDA announced on Nov. 4, 2024, that Siemens Healthcare Diagnostics is recalling Atellica CI Analyzers due to a potential hazard causing falsely elevated Sodium, Potassium, and Chloride test results. The agency issued recall number Z-0597-2025 for the voluntary Class II action affecting 559 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CI Analyzer
Catalog Number: 10947347
UDI-DI Number: 630414229560
Software version: 1.28.51
The hazard
The Atellica CI Analyzer may fail to decrease the IMT Diluent volume remaining percentage as expected, potentially leaving the diluent empty while still displaying that volume remains. This malfunction can cause Sodium (Na), Potassium (K), and Chloride (Cl) test results to be falsely elevated. Quality Control materials demonstrate the same behavior.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Siemens Atellica CH RCRP Test (Aug. 17, 2026), Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), and Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Additional recent recalls of similar products include Beckman Coulter DxH Diluent Recall (Nov. 10, 2025), Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025), and Medica Capillary Tubes Recall (Dec. 31, 2025).
How to tell if you have this one
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.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if the analyzer shows the correct diluent volume by checking the display for accurate percentage remaining.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0597-2025 (November 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0597-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.