Events

Rappel de REAGENT RED BLOOD CELLS ORTHO 0.8% SURGISCREEN

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ORTHO-CLINICAL DIAGNOSTICS.

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
    77182
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2011-08-19
  • 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
    Ortho clinical diagnostics has received complaints of broken vials during shipment for some ortho blood products. studies show that vial to vial contact during the shipping process is one of the key contributors to this vial breakage.

Device

REAGENT RED BLOOD CELLS ORTHO 0.8% SURGISCREEN
  • Modèle / numéro de série
    Model Catalog: 6902316 (Lot serial: VSS399); Model Catalog: 6901939 (Lot serial: DB285A1); Model Catalog: 6901939 (Lot serial: DB286A1); Model Catalog: 6901939 (Lot serial: DB287A); Model Catalog: 711528 (Lot serial: ABB692AX); Model Catalog: 711528 (Lot serial: ABB693AX); Model Catalog: 711228 (Lot serial: BAA588AX); Model Catalog: 711228 (Lot serial: BAA587AX); Model Catalog: 711228 (Lot serial: BAA589AX); Model Catalog: 71901 (Lot serial: 8A694); Model Catalog: 71901 (Lot serial: 8A704); Model Catalog: 719100 (Lot serial: 3SS408); Model Catalog: 719100 (Lot serial: 3SS407); Model Catalog: 719610 (Lot serial: S531); Model Catalog: 719210 (Lot serial: A282); Model Catalog: 711328 (Lot serial: BBB781AX); Model Catalog: 711328 (Lot serial: BBB780AX); Model Catalog: 711328 (Lot serial: BBB779AX); Model Catalog: 6902315 (Lot serial: VS466); Model Catalog: 6902096 (Lot serial: CNF786); Model Catalog: 6902096 (Lot serial: CNF790); Model Catalog: 711328 (Lot serial: BBB778AX)
  • Description du dispositif
    Reagent Red Blood Cells 0.8% SURGISCREEN
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS