Device product
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Z-0940-2014
Product summary
- Event
- Event 67027
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3759
- Official record key
device-enforcement:Z-0940-2014
Official wording
Reason: The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).
Code information: ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265
Distribution pattern: Worldwide Distribution and USA Nationwide.
Derived failure modes
-
Unknown
The ADVIA Chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (QC).