Events

Recall of Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. 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
    Recall
  • Event ID
    RC-2014-RN-01030-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01030-1
  • 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 has confirmed that the dimension hb1c flex reagent cartridge lots listed1 exhibit a positive bias averaging 0.4% [4.4 mmol/mol] haemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp).
  • Action
    Siemens is advising their customers to discontinue use and discard the affected lots. Retesting HbA1c should be considered in cases where all of the following events have occurred: - HbA1c testing was performed on your patient(s) using the affected lot numbers - There may have been adjustments in therapy based solely on the HbA1c value(s), - There have been no follow up HbA1c testing on the patient since the discontinuation of use of the affected lot numbers. This action has been closed-out on 10/08/2016.

Device

Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Dimension Vista Hemoglobin A1c Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)Catalogue Number: DF105ASiemens Material Number: 10483822Lot Numbers: GA4266, BA4273, BA4280, BA4287, GA4301, GA4315, GC4322, GA4343, GA4350, GA4357, GA5013 & GA5020ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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