Events

Recall of IH-1000 (immuno-haematology instrument). 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-01195-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01195-1
  • 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
    Further to a customer complaint, bio-rad have confirmed that in the specific conditions detailed below, the ih-1000 software may lose the link sample/”test in progress”. this loss might lead to a mismatch between the test result and the patient sample.This issue is linked to the sample management when using the “emergency* button” and might occur only in the following conditions:- a not urgent rack (green label) is inserted with more than one sample and;- all the samples on this rack are manually selected as “emergency” by clicking on the “emergency* button”;then once the first emergency sample is processed, the instrument ejects the rack before all processing is completed.- if a rack is then reloaded with new samples in the exact same positions and reinserted in the same slot, the link sample/”test in progress” is lost.
  • Action
    This issue will be permanently corrected in the next IH-1000 software version. This version will be released by the end of Q1 2015. In the meantime, customers should immediately discontinue using the “emergency button” and should process all emergency samples exclusively on the urgent rack.

Device

IH-1000 (immuno-haematology instrument). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    IH-1000 (immuno-haematology instrument). An in vitro diagnostic medical device (IVD)Catalogue Number: 001000VAffected Version - All SoftwareARTG number: 184446
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd