Events

Rappel de THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL

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

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
    18824
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-08-10
  • 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
    Leica received a complaint from a customer regarding bond rtu ttf-1 (product code pa0364) giving positive staining on thymoma tissue which was thought to be negative. the ttf-1 antigen had previously been characterised as staining thyroid and lung tumours only and this is the claim made on the instruction for use (ifu). our investigations following this complaint have demonstrated that ttf-1 has a wider expression than was originally thought.

Device

THYROID TRANSCRIPTION FACTOR-1 ANTIBODY LYOPHILISED MOUSE MONOCLONAL
  • Modèle / numéro de série
    Model Catalog: NCL-TTF-1 (Lot serial: 136439); Model Catalog: NCL-TTF-1 (Lot serial: 136442); Model Catalog: NCL-TTF-1 (Lot serial: 136441S); Model Catalog: NCL-TTF-1 (Lot serial: 136447); Model Catalog: NCL-TTF-1 (Lot serial: 6000563); Model Catalog: NCL-TTF-1 (Lot serial: 6004009); Model Catalog: NCL-L-TTF-1 (Lot serial: L136443); Model Catalog: NCL-L-TTF-1 (Lot serial: L136446); Model Catalog: NCL-L-TTF-1 (Lot serial: 6000568); Model Catalog: NCL-L-TTF-1 (Lot serial: 6002638); Model Catalog: NCL-L-TTF-1 (Lot serial: L136434); Model Catalog: NCL-L-TTF-1 (Lot serial: L136437); Model Catalog: PA0364 (Lot serial: 05918); Model Catalog: PA0364 (Lot serial: 06912); Model Catalog: PA0364 (Lot serial: 07104); Model Catalog: PA0364 (Lot serial: 08679); Model Catalog: PA0364 (Lot serial: 10903); Model Catalog: PA0364 (Lot serial: 10480)
  • Description du dispositif
    TTF-1 PRIMARY ANTIBODIES
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA