Siemens Healthcare recalls Atellica CH B2M reagents that may produce falsely low results for samples between 18.00-30.00 mg/L, affecting diagnostic accuracy. Affected units include all in-date and future lots with specific material numbers.
Potential for falsely depressed auto-diluted results for samples above the measuring interval of 18.00 mg/L, up to 30.00 mg/L, when using the Atellica CH ¿2-Microglobulin (B2M) reagent.
Siemens Healthcare is recalling Atellica CH B2M reagents that can give falsely low results for samples between 18.00 and 30.00 mg/L. This could lead to inaccurate blood tests for certain health conditions. The recall affects all in-date and future lots of the reagent with specific material numbers.
The reagent may produce falsely low results for samples above 18.00 mg/L up to 30.00 mg/L. This means lab tests could show lower levels of B2-microglobulin than actually present, potentially leading to incorrect health assessments.
Lab users who test blood samples with the Atellica CH B2M reagent may be affected. Those testing samples between 18.00 and 30.00 mg/L of B2-microglobulin are most at risk of inaccurate results.
Check for Siemens Material Number (SMN) 11097635 or UDI-DI 00630414595566 on the reagent packaging. All in-date and future lots of the Atellica CH B2M reagent are affected.
Verify the Siemens Material Number (SMN) 11097635 or UDI-DI 0063041459595566 on the reagent packaging.
The reagent may produce falsely low results for samples between 18.00 and 30.00 mg/L of B2-microglobulin, which could lead to inaccurate test results.
Check the Siemens Material Number (SMN) 11097635 or UDI-DI 00630414595566 on the packaging. All in-date and future lots are affected.
The recall record does not mention any remedy or fix for this 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-0599-2025 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0599-2025 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.
