Siemens Healthcare Diagnostics, Inc. Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563
Products Sold
Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901 ***All StreamLAB Analytical Workcells connected to Dimension Vista Systems.
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896 due to Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a Strea. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test.
Recommended Action
Per FDA guidance
Siemens healthcare Diagnostics issued an Urgent Field Safety Notice letter to each customer regarding the issue dated September 2009. The letter informed the user of the problem and volume change instructions. Customers can call Technical Solutions Center at 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