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 Healthcare is recalling Atellica CH Iron3 analyzers used for iron testing because they can give falsely high results. This affects patient test accuracy and requires correction to avoid incorrect diagnoses.
The analyzers can show falsely elevated iron levels when the previous test result was Iron3. This causes a 2-16% positive bias in results, affecting calibrators, quality controls, and patient outcomes.
Healthcare labs using Siemens Atellica CH Iron3 analyzers for iron testing are affected. Patients receiving results from these analyzers may be impacted if the false high results go uncorrected.
Check for Siemens Atellica CH analyzers with Material Number 11537211 or UDI-DI 00630414610849. The recall covers all lots of this specific test.
Verify the software version of your Atellica CH analyzer to ensure it's updated to the latest version that corrects this issue.
Reach out to Siemens Healthcare for specific guidance on correcting the issue if your software is outdated.
The Atellica CH analyzers can produce false high iron results when the previous test was Iron3, causing a 2-16% positive bias in results.
False high iron results can impact calibrators, quality controls, and patient diagnoses, potentially leading to incorrect treatment decisions.
Check your software version and contact Siemens Healthcare for updates or specific instructions to correct the issue.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1549-2024 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1549-2024 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.
