Events

Rappel de VITEK 2 system version 7.01. 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 Biomerieux 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-2015-RN-00132-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-02-18
  • 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-2015-RN-00132-1
  • 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
    Vitek 2 software ver. 7.01 introduced a feature (enable > convention for highest reportable mic) which can be used to modify the ast (antimicrobial susceptibility testing) reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation.The enable > convention for highest reportable minimum inhibitory concentration (mic) configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a > (greater than) symbol. for example, =32 (highest reportable mic) would be modified to >16 which are equivalent for mic testing.Patient isolates function as intended; however, the software does not recognise the two values (e.G. =32 vs. >16) as equivalent, and incorrectly flags the modified value as a deviation.
  • Action
    Biomeriux is requesting their customers that in the event of a QC deviation for one or more of the ATCC strains and antibiotics indicated, to compare the reported MIC value to the expected MIC value. If the values are equivalent, the deviation is subject to the software discrepancy and can be ignored. This issue will be corrected in software release 8.01 This action has been closed-out on 09/08/2016.

Device

VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITEK 2 system version 7.01. An in vitro diagnostic medical device (IVD)Catalogue number: 416381ARTG: Transitioning
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd