FDAFDA · Food and drugs·Recall number Z-0433-2014
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.
Published December 11, 2013 · Recall initiated: May 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution: USA (nationwide) and internationally to Canada.
- Lot
- Siemens Material Number 10800057 (Version VA11B) and 10803188 (Version VA12A)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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