Atellica CH Protein Test (Siemens) – false result risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
Products Sold
Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. due to Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026