FDA Device recall Z-2542-2025
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543 by Siemens Healthcare Diagnostics, citing potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2542-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-11 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Reason
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Identifiers
| code_info | Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2542-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.