Events

Rappel de CALRETININ ANTIBHODY - LIQUID MONOCLONAL

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

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
    145575
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-04-04
  • 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 biosystems recently became aware that novocastra liquid mouse monoclonal antibody calretinin only performed as expected with specific lots of diluents: - ar9352 (lots slbl4196v slbl8154v slbm1997v slbm3199v) - ar9352-cn (lots slbl8154v slbm1997v) - re7133-ce (lot 6035000) - re7133-cn (lot 6035115) in the event that the product is used with diluents other than those listed it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances the absence of adequate staining of tisse is likely to result in a delay in obtaining the results of ihc / ish staining and in a worst-case scenario could cause a delay in the diagnosis or classification of a neoplasm. this notice only applies to novocastra liquid mouse monoclonal antibody calretinin.

Device

CALRETININ ANTIBHODY - LIQUID MONOCLONAL
  • Modèle / numéro de série
    Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029949); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6029060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6025204); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6036060); Model Catalog: NCL-L-CALRET-566 (Lot serial: 6035923)
  • Description du dispositif
    NOVOCASTRA LIQUID MOUSE MONOCLONAL ANTIBODY CALRETININ
  • Manufacturer
    LEICA BIOSYSTEMS NEWCASTLE LTD.

Manufacturer

LEICA BIOSYSTEMS NEWCASTLE LTD.
  • Adresse du fabricant
    NEWCASTLE UPON TYNE
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    HC