Events

Recall of Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. 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-2018-RN-00277-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00277-1
  • 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 that some dimension vista diluent lots may have an incomplete slit on the septum in the cap of the vial. a diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the dimension vista system, due to a reduced volume of diluent being pipetted from the vial.There have been no injuries reported as a result of this issue.
  • Action
    Siemens is advising users to inspect stock and discard any remaining stock of the affected lots. Siemens is not recommending a review of previously generated results.

Device

Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical de...
  • Model / Serial
    Dimension Vista CTNI Sample Diluent and Multi 2 Sample Diluent. An in vitro diagnostic medical device (IVD) CTNI Sample DiluentCatalogue Number: KD692Siemens Material Number: 10445202Lot Number: 7BDA34Expiry Date: 01-06-2018Multi 2 Sample DiluentCatalogue Number: KD694Siemens Material Number: 10483586Lot Number: 7CDA79, 7DDA70Expiry Date: 01-09-2018, 01-11-2018ARTG Numbers: 182774 and 182222Siemens Healthcare - Troponin IVDs
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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