Events

Rappel de i-STAT Alinity Instrument i-STAT Alinity Analyzer Software

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 Abbott Point of Care Canada Ltd.

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
    22433
  • Date de mise en oeuvre de l'événement
    2018-01-12
  • 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: Abbott Australasia Pty Ltd (NZ), Abbott Laboratories NZ, 4 Pacific Rise, Mt Wellington, Auckland 1060
  • Cause
    Through a combination of internal studies and customer reports, the manufacturer has determined that the following may occure:, 1. an increased frequency of quality check failure code 90-02 when testing i-stat cartridges with the i-stat alinity software version osi05 (jams 79a / clew d34)., 2. when testing with i-stat cartridges that report ph, pco2 and po2, an i-stat alinity instrument with software version osi05 (jams 79a / clew d34) that is customized to correct for user entered patient temperature may report incorrect ph and/or pco2 results.
  • Action
    Software to be upgraded

Device

i-STAT Alinity Instrument i-STAT Alinity Analyzer Software

Manufacturer

Abbott Point of Care Canada Ltd
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA