Events

Recall of Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110

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
    53323
  • Event Risk Class
    Class 2
  • Event Number
    Z-0864-2010
  • Event Initiated Date
    2009-08-31
  • Event Date Posted
    2010-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85268
  • 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
    Calibrator, multi-analyte mixture - Product Code JIX
  • Reason
    Siemens healthcare diagnostics, inc. has confirmed high accuracy shifts with dimension vista urca flex reagent cartridge (various lots) when calibrating with some vials from chem 1 calibrator lot 9dm001.
  • Action
    An Urgent Field Safety Notice dated August 31, 2009, was issued to all affected customers. Customers were instructed to discontinue the use of Dimension Vista System CHEM 1 Cal lot 9DM001 and discard any remaining product. If customers have any question they can contact Technical Solutions at 1-800-241-0420.

Device

Device Recall Dimension Vista System CHEM 1 CAL, Catalog Number KC110
  • Model / Serial
    Lot Number 9DM001
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Foreign: Australia, Canada, Denmark, and Malaysia.
  • Product Description
    Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 || The Dimension Vista CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), || Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) methods 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