Device 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.
Z-0344-2014
Product summary
- Event
- Event 66069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 892 units
- Official record key
device-enforcement:Z-0344-2014
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 Codes: 1) 10318424, 2) 10285281
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.