FDA Device recall Z-2086-2025
ADVIA¿ 120/2120/2120i SETpoint Calibrator
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of ADVIA¿ 120/2120/2120i SETpoint Calibrator by Siemens Healthcare Diagnostics, citing products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2086-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-04 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Reason
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
Identifiers
| code_info | Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043. |
|---|
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-2086-2025%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.