PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 11, 2013 Initiated: May 10, 2013 #Z-0433-2014

Product Description

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.

Reason for Recall

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.

Details

Units Affected
262
Distribution
Worldwide Distribution: USA (nationwide) and internationally to Canada.
Location
Newark, DE

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 262.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2013. Severity: Moderate. Recall number: Z-0433-2014.

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