Events

Rappel de MICROSCAN NEG BP COMBO PANEL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DADE BEHRING 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
    146221
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2004-01-21
  • 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
    Potential for mis-identification of p. aeruginosa isolated from cystic fibrosis patients using manual or instrument panel reading and potential for lwered mic results when panels read with autoscan-4.

Device

MICROSCAN NEG BP COMBO PANEL
  • Modèle / numéro de série
    Model Catalog: B1017-50 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-304 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-305 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-72 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-303 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-150 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-136 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-75 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-300 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-302 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-308 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-27 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-135 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-130 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-306 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-307 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-131 (Lot serial: ALL LOT NUMBERS); Model Catalog: B1017-152 (Lot serial: ALL LOT NUMBERS); Model Catalog: B101
  • Description du dispositif
    CONVENTIONAL DRIED GRAM NEGATIVE PANELS
  • Manufacturer
    DADE BEHRING CANADA INC.

Manufacturer

DADE BEHRING CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC