Lower riskMedical device recall · FDA · Published March 13, 2024
Siemens Atellica CH Iron3 Recall: False High Iron Results Risk
Siemens Healthcare recalls Atellica CH Iron3 analyzers for false high iron results affecting patient tests. Fix by updating software or following specific steps.
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
“Siemens Atellica CH Iron3 Recall: False High Iron Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55891-siemens-atellica-ch-iron3-recall-false-high-iron-results-risk. Based on FDA recall #Z-1549-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2024%22&limit=1).
The FDA announced on March 13, 2024, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Iron3 reagents due to a potential for falsely elevated cholesterol and lipid results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin)
Material Number (SMN): 11537211
UDI-DI: 00630414610849
Units affected: 8721
The hazard
The reagents may cause falsely elevated Chol_2, LDLC, and Trig_2 results on Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. This positive bias ranges from 2-16% and impacts calibrator, quality control (QC), and patient results.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has had 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include the Siemens Atellica CH RCRP Test Recall (August 17, 2026), the Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), and the Siemens Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include the Diagnostica Stago Asserachrom HPIA Kit Recall (December 15, 2025), the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026), and the Roche Elecsys Anti-TSHR Assay Recall (November 21, 2025).
How to tell if you have this one
Check for Siemens Atellica CH analyzers with Material Number 11537211 or UDI-DI 00630414610849. The recall covers all lots of this specific test.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version of your Atellica CH analyzer to ensure it's updated to the latest version that corrects this issue.
Contact Siemens Support
Reach out to Siemens Healthcare for specific guidance on correcting the issue if your software is outdated.
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 Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Curacao, St¿Eus, Czech Republic, Denmark, Estonia, Finland,…” 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 42 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-1549-2024 (March 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1549-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.