FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
- Recall number
- Z-2542-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
- Status
- Open, Classified
- Initiated
- 2025-08-11
- Posted
- 2025-09-08
- Terminated
- not on file
- Reason
- Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
- Root cause
- Under Investigation by firm
- Action
- Siemens Healthcare Diagnostics notified consignees on about 08/11/2025 via letter. Customers were instructed to perform QC on each well, track additional reagent consumption (number of tests) to report to Siemens Healthineers for future reimbursement/credit, review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable, and retain this letter with your laboratory records and forward this letter to those who may have received this product. Additionally, consignees were instructed to complete and return the Field Correction Effectiveness Check Form.
- Quantity
- 11,811 units
- 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.
- Lot, serial or model codes
- Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CEK
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28