Lower riskMedical device recall · FDA · Published July 6, 2026
Siemens Atellica CH Urine Albumin Recall: False Results Risk
Siemens Healthcare recalls Atellica CH Urine Albumin REF: 11537225 due to potential false low results for urea nitrogen and hemoglobin A1c tests, affecting diagnostic accuracy.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
✎ GovInfoNow plain-language explainer
Siemens Healthcare is recalling Atellica CH Urine Albumin REF: 11537225 test kits because they may produce false low results for urea nitrogen and hemoglobin A1c tests. This could lead to incorrect health diagnoses if used without proper validation. Read more at govinfonow.com/recall/314276-siemens-atellica-ch-urine-albumin-recall-false-results-risk.
“Siemens Atellica CH Urine Albumin Recall: False Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314276-siemens-atellica-ch-urine-albumin-recall-false-results-risk. Based on FDA recall #Z-2890-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2890-2026%22&limit=1).
The FDA announced on July 6, 2026, that Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urine Albumin REF: 11537225 in vitro diagnostic tests due to potential processing issues. The recall affects 7,018 units distributed worldwide.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Urine Albumin REF: 11537225
Lot codes: All lots within expiry/UDI: 00630414611099
The hazard
Processing of urine albumin assay on the CI analyzers may lead to falsely depressed Atellica CH Urea Nitrogen (UN_c) results and falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results. The issue also causes an increased rate of reaction cuvette QC failures and delayed results due to QC failures.
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 on August 17, 2026, and Syva EMIT 2000 Quinidine Assay Recall on July 13, 2026. Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall on November 22, 2025, and Tosoh ST AIA-Pack Testosterone Recall on June 12, 2026.
How to tell if you have this one
Check for the Atellica CH Urine Albumin REF: 11537225 product with lot numbers within expiry/UDI: 00630414611099. This recall covers specific test kits used in laboratory settings.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Verify the lot number on the test kit to confirm if it falls within the affected range: 00630414611099.
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 including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland,…” 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 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-2890-2026 (July 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2890-2026 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.