Events

Recall of Dimension Vista VLYTE Fluids Diluent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53686
  • Event Risk Class
    Class 2
  • Event Number
    Z-1039-2010
  • Event Initiated Date
    2009-10-22
  • Event Date Posted
    2010-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86323
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    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.
  • 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.

Device

Dimension Vista VLYTE Fluids Diluent
  • Model / Serial
    Catalog number K835
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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 Description
    Dimension Vista V-LYTE Fluids: Diluent catalog number K835
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA