Siemens Healthcare Diagnostics, Inc. — Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
⚠️ Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 11, 2025
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, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.
What's affected?
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
- Lot code
- s
Additional details
Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,811 units.
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