Lower riskMedical device recall · FDA · Published January 20, 2026
Siemens Atellica CH Urine Albumin Recall: False Low Results Risk
Siemens Healthcare recalls Atellica CH Urine Albumin (UAlb) with material number 11537225 due to potential false low results in urine albumin tests. All units are affected.
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
“Siemens Atellica CH Urine Albumin Recall: False Low Results Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50136-siemens-atellica-ch-urine-albumin-recall-false-low-results-risk. Based on FDA recall #Z-1484-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1484-2026%22&limit=1).
The FDA announced on Jan. 20, 2026, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urine Albumin (UAlb) material number 11537225. The device may produce falsely depressed urine albumin results for samples with concentrations above 40.0 mg/dL.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Urine Albumin (UAlb)
Material Number: 11537225
UDI-DI: 00630414611099
Lot Numbers: All lot numbers
Quantity: 4,885 units
The hazard
According to the FDA, affected samples with any urine albumin concentration above the UAlb measuring interval of >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL. This falsely depressed result could lead to incorrect patient assessment.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics, Inc. has 150 other recalls on record since June 7, 2017. Other recent recalls of similar products include Atellica CH Revised C-Reactive Protein (RCRP) recall (Aug. 17, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and Atellica CH Urine Albumin Recall (July 6, 2026). Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), LH One Step Ovulation Test Device Recall (Nov. 22, 2025), and Menopause Test Cassette Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the material number 11537225 on the device. All lot numbers are affected, so every unit of this product is included in the recall.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for the material number 11537225 on the Atellica CH Urine Albumin device.
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 Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia,…” 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 50 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-1484-2026 (January 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1484-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.