FDA Device recall Z-1551-2025
Atellica CH Revised C Reactive Protein (RCRP)
- FDA Device
- Class II
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class II recall of Atellica CH Revised C Reactive Protein (RCRP) by Siemens Healthcare Diagnostics, citing incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1551-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-11 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Reason
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
Identifiers
| code_info | Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots. |
|---|
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-1551-2025%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.