Events

Recall of Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. 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-01393-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01393-1
  • 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 previously confirmed that when whole blood samples are run from the small sample container (ssc), the hba1c value may contain a percent bias range of - 8.2% to + 6.5% (tga ref: rc-2014-rn-00922-1). due to this bias, use of the ssc was withdrawn. as a follow up siemens healthcare diagnostics has confirmed that the ssc can now be used with the dimension vista haemoglobin a1c (hba1c) assay with software version 3.6.2 or higher. the hba1c instructions for use beginning with lot 17205ba will detail use of the ssc.
  • Action
    Siemens is advising users that samples for the HbA1c method can be assayed from a Small Sample Container (SSC) loaded in a “Surplus” sample rack and processed as Routine or STAT. When using an SSC, pipette a minimum of 400 uL of the whole blood sample and load in a “Surplus” sample rack using a 13mm tube insert (Do not run from a “Limited” sample rack).

Device

Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3....
  • Model / Serial
    Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)Assay: Dimension Vista HbA1CCatalogue Number: K3105ASiemens Material Number: 10470481ARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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