Events

Recall of Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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
    RC-2016-RN-00236-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00236-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Siemens healthcare diagnostics has received complaints of “calibrator insert missing” alerts on the affected dimension vista chemistry 3 calibrator. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalogue number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label, the “calibrator insert missing” error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.
  • Action
    Siemens is advising users to use the re-printing options in the Vista system to re-print the affected barcodes. A review of previously generated results is at the discretion of the laboratory director.

Device

Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dimension Vista Chemistry 3 Calibrator. An in vitro diagnostic medical device (IVD)Catalogue number: KC130ASiemens Material Number: 10711579Lot Number: 5MD004ARTG number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA