Recall Z-2542-2025 · CEK Biuret (Colorimetric), Total Protein
Siemens Healthcare Diagnostics, Inc.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
| Date | Sep 8, 2025 (initiated Aug 11, 2025) |
| Status | Open, Classified |
| 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.