Events

Recall of Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samples

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-2013-RN-00112-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00112-1
  • 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
    Roche diagnostics has confirmed that there is an increase in imprecision leading to higher results of the haemoglobin (hb) measurement when using capillary samples on the reflotron systems. testing with venous samples is not affected by this issue.
  • Action
    The use of capillary blood samples with Reflotron is no longer recommended. The package insert will be amended to reflect this change. It is recommended that the recall letter is retained with the Reflotron Hb test strips until the package insert has been updated.

Device

Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitati...
  • Model / Serial
    Reflotron Hb Test Strips, an in vitro diagnostic medical device (IVD) intended for the quantitative measurement of haemoglobin in venous blood samplesMaterial Number: 10744964202All lot numbers
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited