Events

Rappel de VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOMERIEUX CANADA INC..

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
    111383
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2018-02-22
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Internal investigation has demonstrated that in specific cases when a card is processed in and ejected from a slot number greater than 15 or 30 (all vitek 2 compact reader carousels contain 60 physical slots) respectively the final data packet for the card fails to be accepted by the computer and the isolate status remains at "preliminary". when the anomaly occurs subsequent data for current and future cards will not be transferred to the computer until the offending data packet is removed. since the card has completed processing as evidenced by the card ejection from the vitek 2 compact reader the results indicated in the lab report are the final results. as the card data for the ejected card will be lost after record removal it is recommended the user print the lab report prior to removal of the record.

Device

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 27530 (Lot serial: All)
  • Description du dispositif
    VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.