Z-2542-2025Class II

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

Name: Z-2542-2025 Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-08-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-08-11 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543 on 2025-08-11. FDA classified it as Class II and gives the reason as "Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2542-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-11
Posted: 2025-09-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Product code: CEK Biuret (Colorimetric), Total Protein
Reason for recall: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2542-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2542-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-08

Product code CEK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)