ADVIA 1800 System Software V2 — Class II medical device recall Z-0345-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2013-11-27, distributed nationwide. Siemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to Ration Parameters Flagging Beh
| Recall number | Z-0345-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-09-03 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2017-03-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, GB, SE, TR, TW, VN |
| Quantity | 1,366 units |
| Reason classes | software |
Product
ADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0345-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.