FDA Device recall Z-0346-2014
ADVIA 2400 System Software V4.01
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of ADVIA 2400 System Software V4.01 by Siemens Healthcare Diagnostics, citing siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0346-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-03 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Reason
Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Behavior for All Software Versions utilized on ADVIA 1200, 1650, 1800 or 2400 Chemistry Systems.
Identifiers
| code_info | Product Code: 10639265 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0346-2014%22
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