Events

Recall of Bio-Rad IH-1000 Analyser

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
    14664
  • Event Initiated Date
    2013-06-14
  • 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
    An error relative to the liquid reagents management (test cell or anti-serum vials) might occur if the following conditions are present:, 1. ih-1000 is in in status :ready to start"., 2. the user requests the unloading of a reagent rack while the system is creating the internal batch., 3. another is loaded immediateky afterwards in the same position., if all three conditions are present the ih-1000 may not use the full set of iquid reagents required to perform the tests of the ongoing batch., due to a software failure, the system mau only use the vial palced in the first position of the re-loaded rack for all the tests of the ongoing batch.
  • Action
    Software to be upgraded

Device

Bio-Rad IH-1000 Analyser

Manufacturer

Bio-Rad Laboratories Inc