Device product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Z-2542-2025
Product summary
- Event
- Event 97398
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11,811 units
- Official record key
device-enforcement:Z-2542-2025
Official wording
Reason: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Code information: Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.