Events

Recall of Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)

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-00922-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00922-1
  • 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 confirmed that when whole blood samples are run from small sample container (ssc – ks860 smn 10472099)), hba1c values may exhibit a percent bias ranging from -8.2% to +6.5% compared to results from the primary container. the percent bias range is a percentage of the hba1c result; it is not % hba1c units.
  • Action
    Siemens Healthcare Diagnostics is advising customer not to use Small Sample Containers (SSC) when running whole blood samples with Dimension Vista HbA1c assay and to process HbA1c samples according to the Instructions For Use for Primary Tubes or Sample Cups i.e. samples should be mixed by inversion (gently invert the tube ten times) or in a rocker mixer to obtain uniform distribution of erythrocytes prior to testing. Users are also advised that the need for a look back at previously reported results should be discussed with the laboratories Medical Director.

Device

Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used ...
  • Model / Serial
    Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)Siemens Material Number (SMN): 10470481Catalogue Number: K3105AAll in-date lot numbers are affected ARTG Number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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