Recall of Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). 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 has received complaints of inaccurate results after calibration of hb1c (df105a). accuracy shifts of up to 27%, both high and low, have been reported on qc and patient samples. the shift observed with qc material is consistent with the direction and magnitude of the shift observed with patient samples.
  • Action
    End user to use updated scaler values for calibration of all affected lots.


  • Model / Serial
    Dimension Clinical Chemistry System - Haemoglobin A1c (HbA1c). An in vitro diagnostic medical device (IVD) Catalogue Number: DF105ALot Numbers: GA3169, GA3162, GA3141, GA3134, GA3113 & GA3099ARTG Number: 181689
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source