Events

Recall of Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)

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-2014-RN-00334-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00334-1
  • 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 a complaint for under-recovery of patient samples with the dimension vista csa flex reagent cartridge when whole blood samples are run from small sample container (ssc). investigations by siemens have confirmed that csa, as well as csae, under-recovers by 18% to 44% when whole blood samples are run from ssc.
  • Action
    Siemens is advising end users to cease using small Sample Containers when running whole blood samples with Dimension Vista CSA and CSAE assays. A review of previously reported results is recommended for cyclosprine samples run in Small Sample Containers. This action has been closed-out on 01/02/2016.

Device

Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE)
  • Model / Serial
    Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent CartridgeDimension Vista CSA:Catalogue Number: K4089Siemens Material Number: 10445139Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BBDimension Vista CSAE:Catalogue Number: K4108Siemens Material Number: 10445142Lot Numbers: 13157BC & 13429BDARTG Number: 182779
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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