Z-1205-2010

Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896...

Name: Z-1205-2010 Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-09-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-09-01 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB... on 2009-09-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1205-2010
Status: Terminated
Initiated: 2009-09-01
Posted: 2010-03-24
Terminated: 2010-09-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 81 units
Distribution: Worldwide distribution: USA, Australia, Canada, France, Germany, Malaysia, Netherlands, Spain, and Switzerland.
Product codes and lots: 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.

Product code CDT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)