Events

Rappel de DIMENSION CHEMISTRY WASH

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
    63778
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-05-17
  • 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 healthcare diagnostics has received complaints of chemistry wash causing qc and patient sample result shifts on ctni ltni ft4 tsh pbnp and lpbn when using chemistry wash lots rd23031 rd23111 rd23241 rd23311 rd23391 and rd23461. these lots shipped between 12/12/2012 and 3/22/2013. internal investigation has confirmed shifts can be encountered in two scenarios: 1. when an affected lot of chemistry wash is placed on the instrument following an unaffected lot a negative bias will be seen on ctni ltni tsh pbnp and lpbn. a positive bias will be seen on ft4. 2. if any of these assays are calibrated using an affected lot of chemistry wash qc should return within range but when a subsequent unaffected chemistry wash lot is placed into use a positive bias will be seen on ctni ltni tsh pbnp and lpbn. a negative bias will be seen on ft4.

Device

DIMENSION CHEMISTRY WASH
  • Modèle / numéro de série
    Model Catalog: 10445052 (Lot serial: RD23031); Model Catalog: 10445052 (Lot serial: RD23111); Model Catalog: RD701 (Lot serial: RD23241); Model Catalog: 10445052 (Lot serial: RD23241); Model Catalog: RD701 (Lot serial: RD23311); Model Catalog: RD701 (Lot serial: RD23031); Model Catalog: RD701 (Lot serial: RD23391); Model Catalog: 10445052 (Lot serial: RD23391); Model Catalog: RD701 (Lot serial: RD23461); Model Catalog: 10445052 (Lot serial: RD23461); Model Catalog: RD701 (Lot serial: RD23111); Model Catalog: 10445052 (Lot serial: RD23311)
  • Description du dispositif
    DIMENSION CHEMISTRY WASH
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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