Events

Recall of IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn 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-2012-RN-01215-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01215-1
  • 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
    There have been reports of results not being interpreted in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software doesn't include the reaction of this well when sending the result to the laboratory host (result code-30).This can occur in the following situations;1. ih-com software is connected to the laboratory host through astm communication mode, and2. an "abo not interpretable" result is obtained due to a reaction "?" or "+-" or "dp" in the anti-ab well of the id-card intended for abo forward grouping, and3. the "second reading" option is deactivated and ih-com results are directly sent to the host, or4. the "second reading" option is activated by the the "not interpretable" result is obtained in ih-com directly saved and sent to host without a manual selection by the user in abo scrollbar.
  • Action
    Bio-Rad Laboratories will be providing work around instructions in the customer letter. A software update will be implemented to correct the problem.

Device

IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood groupin...
  • Model / Serial
    IH-Com Kit Full version (Data management and Result Interpretation Software for ABO blood grouping). An in vitro diagnostic medical device (IVD)Used for ABO Blood GroupingAn in vitro diagnostic medical device (IVD)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd