Events

Recall of Dimension Vista RF Flex Reagent Cartridge (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 Ltd Diagnostics Division.

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-2013-RN-00750-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00750-1
  • 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 confirmed an increase in the rate of abnormal assay errors (e143: abnormal assay) with the dimension vista rf flex reagent cartridge lot 12283ma. the errors can occur on calibration, qc and/or patient sample. any result produced with the abnormal assay error is deemed non-reportable as stated in the dimension vista operator's guide (section 5-49).
  • Action
    Siemens Healthcare is advising users to discontinue use and discard remaining inventory.

Device

Dimension Vista RF Flex Reagent Cartridge (an in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dimension Vista RF Flex Reagent Cartridge (an in vitro diagnostic medical device (IVD)Catalogue Number: K7068Lot Number: 12283MAARTG Number: 178155
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA