Medical Device Recall: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Siemens Healthcare Diagnostics, Inc. · August 11, 2025
Reason for Recall
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
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, 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.
States Affected
NATIONWIDE
Quantity Affected
11,811 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2542-2025
Status: ongoing
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