Events

Recall of Dimension Clinical Chemistry System and Dimension Vista System. 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-2017-RN-00002-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00002-1
  • 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 determined that some lots of ammonia (amm) reagent used on both the dimension® and dimension vista® systems do not meet the 60-day calibration interval claim due to reagent instability and results may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results; which may cause laboratories to recalibrate more frequently than the of 60-day claim in the instructions for use (ifu).
  • Action
    Siemens is advising customers to discard affected lots and to use alternate lots instead. Customers are also to check the acceptability of the calibration and QC.

Device

Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical de...
  • Model / Serial
    Dimension Clinical Chemistry System and Dimension Vista System. An in vitro diagnostic medical device (IVD).Dimension Clinical Chemistry SystemAssay: Ammonia AMMCatalogue No: DF119SMN: 10711991Lots: FB7152 (Exp 1/6/17), EB7180 (Exp 29/6/17), BA7194 (Exp 13/7/17), EA7223 (Exp 11/8/17), BA7250 (Exp 7/9/17)Dimension Vista SystemAssay: Ammonia AMMCatalogue No: K3119SMN: 10711992Lots: 16187BE (Exp 5/7/17), 16225BB (Exp 12/8/17), 16265AB (Exp 21/9/17)ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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