Events

Recall of Device Recall Dimension Vista VLYTE Standard A

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
    56703
  • Event Risk Class
    Class 2
  • Event Number
    Z-0139-2011
  • Event Initiated Date
    2010-08-19
  • Event Date Posted
    2010-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94324
  • 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
    Electrode, ion specific potassium - Product Code CEM
  • Reason
    High potassium content in the affected lots results in the potential for low potassium recovery for dilution check, qc and patient samples when run on the dimension vista system.
  • Action
    Siemens sent an Urgent Field Safety Notice (dated "August 2010") to customers identifying the product, the problem and the action to be taken. Customers were instructed on how to continue testing until new lots of the recalled product were available and asked to complete and fax a Field Correction Effectiveness Check to 301-631-8467 to confirm receipt of the Urgent Field Safety Notice. For technical questions or concerns customers were instructed to contact the Siemens Technical Solutions Center at 800-441-9250.

Device

Device Recall Dimension Vista VLYTE Standard A
  • Model / Serial
    KA0C03 EXP 3/24/11, KA0D01 EXP 4/14/11, KA0E01 EXP 5/5/11, KA0E02 EXP 5/19/11, KA0F01 EXP 6/3/11, AND KA0G01 EXP 7/8/11
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA, Nationwide Distribution
  • Product Description
    Dimension Vista V-LYTE Standard A, Catalog No K820 || For the calibration of Na+/K+/Cl- on the Dimension vista System.
  • 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