Events

Recall of D-10 Haemoglobin Testing System. 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 Bio-Rad Laboratories 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-2014-RN-00280-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00280-1
  • 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
    On a rare occasion, the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample. the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Action
    Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016.

Device

D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)Catalogue Number: 220-0220
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd