Lower riskMedical device recall · FDA · Published August 11, 2025
Siemens Atellica UCFP Test May Give False Low Results - Recall
Siemens Healthcare recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests with material number 11097543 due to potential false low results in patient testing.
Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) tests that may give false low results in patient testing. This could lead to inaccurate quality control or calibration results, affecting diagnosis and treatment decisions. Read more at govinfonow.com/recall/51647-siemens-atellica-ucfp-test-may-give-false-low-results-recall.
“Siemens Atellica UCFP Test May Give False Low Results - Recall.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51647-siemens-atellica-ucfp-test-may-give-false-low-results-recall. Based on FDA recall #Z-2542-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2025%22&limit=1).
The FDA announced on Aug. 11, 2025, that Siemens Healthcare Diagnostics is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) due to the potential for falsely depressed or delayed results. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
Material Number: 11097543
Test Code: UCFP
UDI-DI: 00630414279206
Lot numbers: All lot numbers
Units affected: 11,811
The hazard
The recall cites the potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. The FDA said this could impact diagnostic accuracy.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics has had 150 other recalls since June 7, 2017. Other recent recalls of similar products include Vivoo Protein Test Recall (Nov. 22, 2025), Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (Dec. 11, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the material number 11097543 on the test kit. The product is sold under the Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP) name with test code UCFP.
Brand
Siemens Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Kit
Look for the material number 11097543 on the test kit label.
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 Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt,…” 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
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-2542-2025 (August 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2542-2025 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.