FDAFDA · Food and drugs·Recall number Z-2561-2014
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
Published September 10, 2014 · Recall initiated: August 13, 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
May not perform as intended under certain conditions, causing the release of results to the Laboratory Information System (LIS) 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
- US Nationwide Distribution
- Lot
- EasyLink Informatics System V4.0/V5 Siemens Material Number (SMN) 10444799, 10444800, 10487219
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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