Device product
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens StreamLAB(R) Automation Solutions. It provides autoverification, integrated QC capabilities, browser-based connectivity supporting up to 25 concurrent users, remote services to help keep systems running optimally and also has audit trail capabilities.
Z-0433-2014
Product summary
- Event
- Event 65147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 262
- Official record key
device-enforcement:Z-0433-2014
Official wording
Reason: Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.
Code information: Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
Distribution pattern: Worldwide Distribution: USA (nationwide) and internationally to Canada.
Derived failure modes
-
Unknown
Under certain conditions the system may not perform as intended, causing the release of results to the Laboratory Information System that should have been held for manual review due to auto-verification rules or the delay/omission of result transmission to the LIS.