Events

Recall of IH-1000. 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-2013-RN-00593-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00593-1
  • 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
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore this issue might lead to a wrong result released to the host if the 3 following conditions are met:1 a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, 2. this negative result is consistent with the global interpretation of the test and, 3. the system is configured without the second reading function activated for all tests results.
  • Action
    Bio-Rad are providing work around instructions as an interim measure. A software update will be implemented to permanently correct the issue.

Device

IH-1000. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    IH-1000. An in vitro diagnostic medical device (IVD)All software versions are affectedProduct reference: 001000ARTG Number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd