Events

Rappel de Phadia 1000 Instrument. 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 Abacus ALS 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-01072-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-30
  • 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-01072-1
  • 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
    An error handling issue for code 7-101, liquid sensor error, has been reported on the phadia 1000 instrument. when error 7-101 occurs, immunocap dispensing will stop, whereas already dispensed samples will continue to be processed. due to an isw issue, the “retry” command, used to clear this error, does not function properly and there will be no further pumping of wash and rinse solution during the processing of the dispensed samples.Thus, if the error code 7-101occurs during the assay run, there may be a shortage of wash and rinse solution that will affect assay performance and test results if the operator chooses to respond to the error with the “retry” command.
  • Action
    A mandatory ISW update will be provided to correct the problem. In the meantime, Abacus ALS advise you to take the following actions: - All instrument operators are to be instructed that if the 7-101 error occurs during an assay run, the “Stop” command must be selected. This will abort the run and results flagged as erroneous. Results from the assay run should not be approved. - Review records to determine if error 7-101 has occurred. If the instrument error message “7-101 LIQIUD SENSOR ERROR (Wash upper ON lower OFF)” has been reported. Abacus ALS will be contacting you to assist with this. - Fill in and return the supplied acknowledgement form - Phadia AB will have a revision of the current ISW version available soon. Technical Support staff will contact users in regards to the scheduling of this mandatory software installation.

Device

Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Phadia 1000 Instrument. An in vitro diagnostic medical device (IVD)Article Number: 12-3800-01All instrument software (ISW) versionsAll Lot/Serial NumbersARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd