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Recall Observatory FDA recall evidence

Device product

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

Z-2542-2025

August 11, 2025

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
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

    reason.no_named_rule · v1.0.0

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