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
    14800
  • Event Initiated Date
    2013-06-13
  • 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
    Under specific conditions inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed., this issue might lead to a wrong result released to the host if all the 3, following conditions are met:, 1. a result is returned as negative while the reaction is positive, dp, 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
    Software to be upgraded

Device

Bio-Rad- IH-1000 Analyser

Manufacturer

Bio-Rad Laboratories Inc