Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

Recall date
August 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2542-2025
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
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, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece,…

Why it was recalled

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

Get recall alerts

Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Siemens Healthcare Diagnostics, Inc.