Recall of Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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 for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista chem 1 cal lot 3gm081. investigation by siemens confirms that qc and patient samples show low recovery of mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • Action
    CHEM 1 CAL lot 3GM081 expired on 1 July 2014; however, Siemens is advising their customers to immediately calibrate MG with an alternate lot of CHEM 1 CAL if a calibration of MG with this lot of CHEM 1 CAL is still active. Siemens recommends that the content of this letter and review of previous testing should be discussed with your Medical Director. This action has been closed-out on 03/06/2016.


  • Model / Serial
    Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro diagnostic medical device (IVD).Catalogue Number: KC110Siemens Material Number: 10445169Lot Number: 3GM081ARTG number: 182222
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source