Events

Recall of Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)

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
    13871
  • Event Initiated Date
    2012-12-04
  • 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
    In case of non interpretable results in the anti-ab well (abo3) of id-cards intended for abo forward grouping, the ih-com software does not include the reaction of this well (result code-30) wheh sending the result to the laboratory host. the issue can only occur if the following conditions are met:, 1. ih-com software is connected to the laboratory host through astm communication mode and,, 2. an "abo not interpretable" result is obtained due to a reaction "?" or "+/-" or "dp" in the anti-abwell of an id-card ** intended forabo forward grouping and, 3. the "second reading" option is deactivated and in-com results are directly sent to the host, or, 4. the "second reading" option is activated but the "not interpretable" result obtained in ih-com is directly saved and sent to the host without a manual selection by the user in abo scrollbar.
  • Action
    Software to be upgraded

Device

Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)
  • Model / Serial
    Model: Item number: 09000, Affected: Lot Number: 03.043/03.052/03.0.59
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc