Events

Rappel de Phadia 1000 Instrument (Allergy testing system). 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-2014-RN-01290-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-12-11
  • 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-2014-RN-01290-1
  • 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
    A mismatch between the sample id and the test result reported will occur if the following specific circumstances occur. 1. a barcode reading error 0-1502 occurs (error #1)2. the operator then selects “enter id” in order to manually assign the sample tube a sample id number3. another error message of any kind occurs (error #2) before the sample id is entered (the “enter id” screen remains open on the instrument)4. when more than 5 minutes elapse after “error #2” occurs, but before the “enter id” screen is closed by the operator, a third error (error #3) occurs which requires a response from the operator5. the operator then closes the “enter id” screen by touching either the “rack pass” or “back” buttons on the touch screenthis will result in a mismatch between for all subsequent sample racks in that run.
  • Action
    Abacus ALS is providing a software update to correct the issue. Until the software update is installed end users are requested to take the following actions: If a user is presented with a 0-1502 error, BAR CODE ERROR (Sample Rack): - select “Pass” (i.e., do not select “Enter ID”), or - do nothing (since the error will be automatically released after more than five minutes). Any sample with a barcode reading error will then not be processed. It may be processed later in the run after the sample rack has been ejected from the sampling area. This action has been closed-out on 04/04/2017.

Device

Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Phadia 1000 Instrument (Allergy testing system). An in vitro diagnostic medical device (IVD) Part Number: 12-3800-01 ARTG Number: 192561
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd