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
    104121
  • 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 reader assembly is the optics component of the instrument that translates pcr amplification into curves for an algorithm or user to interpret results. if the filter/lens pair inside the reader assembly becomes loose the readers can produce curves with excess variability - the curve may appear shaky or oscillatory around expected curve. the issue originates in manufacture and does not get worse over time. when using the instrument for ivd assays there is the potential for false positive results. when using the instrument for open system assays the issue is not expected to cause false results because the instrument produces the curve but does not interpret the curve (i.E. the curve for open system assays is to be interpreted by the user not the instrument algorithms). assay development by the user would have incorporated any [consistent-overtime] curve abnormalities.

Device

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

Manufacturer

BECTON DICKINSON CANADA INC.