Events

Rappel de DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device (IVD)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Beckman Coulter Australia Pty 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
    RC-2017-RN-00705-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00705-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Beckman coulter has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use (table 10.4) stating that “the run sample is inaccessible”. results generated in this scenario may be erroneous. additionally:- the message on the results screen/printout reads “instrument temperature” instead of “instrument temperature out of range”- the results are transmitted to the laboratory information system (lis) without the accompanying “instrument temperature out of range” message. using the auto-transmit option could lead to the release of erroneous results to the lis.If the instrument is operating out of the temperature range, the warnings on the screen are ignored and the results used, then:- these cbc, wbc-diff or cbc/wbc-diff results may be erroneous.- if these erroneous results are released to the physician, this could result in inappropriate patient management.
  • Action
    Beckman will be correcting the issue in a future software update. In the interim, the following instructions are provided to users: - When the message “Instrument Temperature Out of Range” or “Instrument Temperature” is displayed on the system or printouts, do not report the patient results. - Ensure the laboratory ambient temperature is within specifications (18°C - 32°C) when processing samples. - Disable the auto-transmit option if there is a potential for the operational temperature to be exceeded. - Consult with your Medical Director to determine if a retrospective review of results is warranted.

Device

DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    DxH 500 Haematology Analyser, with software version 1.0.2. An in vitro diagnostic medical device (IVD)Reference Number: B40601ARTG Number: 208574
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd