Events

Rappel de BD MAX SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON 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
    122036
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-07-29
  • 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
    The bd max system is capable of automated extraction and purification of nucleic acids from multiple specimen types and is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical industrial and research settings. the instrument has both "open system" and ivd functionality. there are two issues concerning the heater and the reader. these issues are being treated by health canada as separate recalls and therefore at the request of health canada a separate notice has been prepared for each. the heater is part of an assembly that controls thermal cycling during polymerase chain reaction (pcr) and opening of the wax valves in the consumable [pcr] cartridge. individual heaters may fail to reach target temperatures if a defect ("shunt") is present. the magnitude of the potential temperature error is as high as 10 c lower than expected however most estimates are near 2 c lower than normal (instrument spec is temperature +/- 2 c). there is the potential for false negative results.

Device

BD MAX SYSTEM
  • Modèle / numéro de série
    Model Catalog: 441916 (Lot serial: CM0094); Model Catalog: 441916 (Lot serial: CM0006)
  • Description du dispositif
    BD MAX Instrument
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.