Events

Rappel de VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits

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-00378-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-01
  • 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-00378-1
  • 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 issue related to out-of-range-low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258, the package insert qc strain, has been identified in association with the vitek 2 ast-ys06 and ast-ys07 test kits.Internal investigation at the manufacturing site has observed the oorl fct qc results for candida krusei atcc 6258. internal testing of fct with additional isolates shows a trend to call one to two doubling dilutions low. candida krusei are intrinsically resistant to fct and are therefore forced "resistant" in vitek 2 software (as of version 7.01); the vitek® 2 7.01 fct forcing rule does not apply to other candida species. user reports have been limited to the atcc 6258 qc strain; however, impact to patient results for candida krusei and other yeast cannot be ruled out.
  • Action
    For the referenced test kits (VITEK 2 AST-YS06 or AST-YS07), laboratories are advised to not report Flucytosine (FCT) results for any organism until the new formulation (fct02n) is released. This issue will be resolved with the release of a new Flucytosine (fct02n) formulation. The estimated timeframe for introduction of cards with the new Flucytosine formulation is six months. This action has been closed out on 09/08/2016.

Device

VITEK2 AST-YS06 & VITEK2 AST-YS07 Test Kits
  • Modèle / numéro de série
    VITEK2 AST-YS06 & VITEK2 AST-YS07 Test KitsCatalogue numbers: 412610 & 414967Lot numbers: 286303720, 287314910, 287314912, 287317310, 287318920, 287321940, 287323520, 287329620, 287330520, 287334810, 287336220, 287340140, 287344620, 287344622, 287346710, 287350120 & 287350910Pack size: 20 CardsARTG number: 196634
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd