Events

Rappel de ADVIA 560 HEMATOLOGY ANALYZER

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

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
    53042
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-03-11
  • 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
    Siemens has identified that software version 1.4.2133 does not trigger the following flags: - the w warning flag for detecting small sample volumes when using the international software configuration. if there is not enough sample volume of the patient's blood when the sample is run results may be lower than expected. this can occur if the required sample volume as defined in the advia 560 hematology system operator's guide is not followed. - the g or l morphology flags for immature granulocytes (ig) and atypical lymphocytes (atyp) respectively. the results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should. as defined in the advia 560 hematology system operator's guide the immature granulocytes and atypical lymphocyte morphology flags should be raised when the presence of morphologically abnormal cells is suspected indicating that a manual count on a stained smear needs to be performed.

Device

ADVIA 560 HEMATOLOGY ANALYZER
  • Modèle / numéro de série
    Model Catalog: 11170842 (Lot serial: S020099)
  • Description du dispositif
    ADVIA 560 HEMATOLOGY ANALYZER
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC