Siemens Healthcare Diagnostics, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Part Number: 1000046623.
Products Sold
Part Number: 1000046623.
Siemens Healthcare Diagnostics, Inc. is recalling EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrate due to incorrect results may be transmitted to LIS. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
incorrect results may be transmitted to LIS
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026