Z-1039-2010

Dimension Vista V-LYTE Fluids: Diluent catalog number K835

Name: Z-1039-2010 Dimension Vista V-LYTE Fluids: Diluent catalog number K835
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2009-10-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-10-22 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Vista V-LYTE Fluids: Diluent catalog number K835 on 2009-10-22. The reason FDA records is "Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1039-2010
Status: Terminated
Initiated: 2009-10-22
Posted: 2010-03-10
Terminated: 2010-12-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension Vista V-LYTE Fluids: Diluent catalog number K835
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
FDA root cause: Other
Action: The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
Quantity in commerce: 150 units
Distribution: The product was shipped to medical facilities nationwide. The product was also shipped to Australia, Canada, Belgium, France, Germany, Italy, Japan, Malaysia, New Zealand, Netherlands, Portugal, Spain, South Korea, and Switzerland.
Product codes and lots: Catalog number K835

Product code JJE

K051087Class IDimension Vista Integrated SystemDade Behring, Inc. / cleared 2005-07-11

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)