Siemens Atellica CH B2M Reagent May Give False Low Results
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.
Lower-risk recall
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.
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What happened, in plain English
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. Read more at govinfonow.com/recall/53669-siemens-atellica-ch-b2m-reagent-may-give-false-low-results.
Source Summary by GovInfoNow · govinfonow.com/recall/53669-siemens-atellica-ch-b2m-reagent-may-give-false-low-results · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0599-2025
Cite this page
“Siemens Atellica CH B2M Reagent May Give False Low Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53669-siemens-atellica-ch-b2m-reagent-may-give-false-low-results. Based on FDA recall #Z-0599-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0599-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Siemens Healthcare- Category
Medical device
What to do — step by step
Check Reagent Lot
Verify the Siemens Material Number (SMN) 11097635 or UDI-DI 0063041459595566 on the reagent packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary,…” 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 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0599-2025 (October 21, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0599-2025 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.