EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
Hazard
incorrect results may be transmitted to LIS
What You Should Do
Remedy
Siemens issued an "Urgent Device Correction" letter dated July 2009. The letter informed the user of the affected product including instructions for avoiding the problem. For further information, contact Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
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Products
EasyLink Informatics System included with the Dimension Vista System.
The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as
- Brand
- Siemens Healthcare Diagnostics, Inc.
- UPC
- Part Number: 1000046623.
Units Affected
359 units