Siemens Healthcare Diagnostics, Inc. Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
Catalog number K825
Products Sold
Catalog number K825
Siemens Healthcare Diagnostics, Inc. is recalling Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825 due to Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sens. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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