Events

Recall of Bio-Rad IH-1000 software

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Bio-Rad Laboratories Inc.

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
    17647
  • Event Initiated Date
    2014-11-07
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Reason
    Bio-rad has confirmed that under specific conditions, the ih-1000 software may lose the link sample/"test in progress". this loss, might, in the worst case, lead to a mismatch between the test result and the sample., this issue is linked to the sample management when using the "emergency* button" and might occur only in the following conditions:, 1. a not urgent rack (green label) is inserted with more than one sample and ;, 2. 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., 3. 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
    Software to be upgraded

Device

Bio-Rad IH-1000 software
  • Model / Serial
    Model: Catalogue Number: 001000V, Affected: , Software version: All versions
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc