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

FDA device recall Z-2542-2025 · posted 2025-09-08 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

CEK

Quantity affected

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

Date initiated

2025-08-11

Date posted

2025-09-08

Location

Tarrytown, NY