Siemens Healthcare recalls Atellica B2M assay lot 211446 due to potential inaccurate results. This may lead to misdiagnosis of kidney disease. Affected units have specific Siemens material numbers and lot numbers.
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L
“Siemens Atellica B2M Assay Recall: Inaccurate Results Risk Misdiagnosis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61481-siemens-atellica-b2m-assay-recall-inaccurate-results-risk-misdiagnosis. Based on FDA recall #Z-0440-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0440-2022%22&limit=1).
The FDA announced on 2021-12-01 that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH ¿2-Microglobulin (B2M) -M) Assay due to potential positive or negative bias in patient sample results. The agency issued recall number Z-0440-2022 for the Class II voluntary recall.
The recall addresses a bias in ¿2 Microglobulin (B2M) Reagent Lot 211446 affecting quality control and patient sample results. The record states there is a positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias of up to -10.5% at approximately 15 mg/L.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since 2017-06-07. Other recent recalls of similar products include Siemens Atellica CH RCRP Test (2026-08-17), Beckman Coulter Emit 2000 Quinidine Assay (2026-07-13), and Siemens Atellica CH Urine Albumin Recall (2026-07-06). Other recent recalls of similar products include Bioporto ProNephro AKI Reagent Kit (2026-05-18), Biomerieux VITEK 2 AST-N461 Test Kit (2026-07-24), and Roche Elecsys Anti-TSHR Assay (2025-11-21).
How to tell if you have this one
Check for Siemens Material Number 11097635 and Lot Number 211446 on the kit. The kit is used for in vitro diagnostic testing of B2M levels in human serum and plasma.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for Siemens Material Number 11097635 and Lot Number 211446 on the assay kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, CO, MA, MD, MS, NC, NE, NH, OH, VA, WI and the countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czech Republic, Denmark, Ecuador, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Maryland, Massachusetts, Mississippi, Nebraska, New Hampshire, North Carolina, Ohio, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0440-2022 (December 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0440-2022 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.