Rappel de DIMENSION VISTA SYSTEM - HEMOGLOBIN A1C (HBA1C) ASSAY

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
    56973
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-08-19
  • Pays de l'événement
  • 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
    An internal study has show that variance is introduced into the % hba1c result when the sample is run from the small sample container (ssc). previously (vc-14-03) cyclosporine was identified as under-recovering when run from the ssc. capa investigation has found that an unintentional dilution of the sample occurs when whole blood samples are transferred from the ssc to the aliquot well. %hba1c is a ration of two components. with the % hba1c the unintentional dilution of sample introduces variance into the final %hba1c result.

Device

  • Modèle / numéro de série
    Model Catalog: K3105A (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 14132BA); Model Catalog: K3105A (Lot serial: 14132BA); Model Catalog: 10470481 (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 13273BA); Model Catalog: K3105A (Lot serial: 13273BA); Model Catalog: 10470481 (Lot serial: 13294BA); Model Catalog: K3105A (Lot serial: 13294BA); Model Catalog: 10470481 (Lot serial: 13308BA); Model Catalog: K3105A (Lot serial: 13308BA); Model Catalog: 10470481 (Lot serial: 13329AA); Model Catalog: K3105A (Lot serial: 13329AA); Model Catalog: 10470481 (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 14006AA); Model Catalog: 10470481 (Lot serial: 14006AA)
  • Description du dispositif
    Dimension Vista System-Hemoglobin A1C (HBA1C) A
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
  • Source
    HC