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.
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