Device 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.
Z-0345-2014
Product summary
- Event
- Event 66069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1366 units
- Official record key
device-enforcement:Z-0345-2014
Official wording
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.
Code information: Product Code: 10639244
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Vietnam.
Derived failure modes
-
Unknown
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.