Events

Rappel de Bio-Rad IH-Com Kit Fullversion (Data management and result Interpretation)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Bio-Rad Laboratories Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    13871
  • Date de mise en oeuvre de l'événement
    2012-12-04
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Bio-Rad Laboratories Ltd, 189 Bush Road, Rosedale, AUCKLAND 0632
  • Cause
    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)
  • Modèle / numéro de série
    Model: Item number: 09000, Affected: Lot Number: 03.043/03.052/03.0.59
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc