Events

Recall of Dimension Vista Systems - Cyclosporine (CSA) 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-01297-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01297-1
  • 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 regarding variability in recovery of qc and patient results with the dimension vista csa flex reagent cartridge lots 12300bb, 12318bb, and 13011bb. investigation by siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with csa concentrations below 125 ng/ml. daily qc checks can detect performance variations in this assay.
  • Action
    Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a review of previously generated results is at the discretion of the laboratory.

Device

Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medic...

Manufacturer

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