Class II — Siemens Healthcare Diagnostics
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring. |
| Quantity | 892 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam. |
| Initiated | 2013-09-03 |
| Classified | 2013-11-18 |
| Terminated | 2017-03-07 |
| Recall number | Z-0344-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics (Z-0344-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66069/
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