Events

Rappel de VISUDEP-F FROZEN FACTOR XII DEFICIENT PLASMA

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

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
    60723
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-08-28
  • 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
    Affinity biologicals has determined that there was an error in the dilution factors provided in the preparation of the calibration curve section of the ifu (instructions for use) provided with these products. the provided dilution factors were: 1/10 1/20 1/40 1/180 1/160. the correct dilution factors are: 1/10 1/20 1/40 1/80 1/160. this is a typographical error only the description and volumes listed in the table preparation of calibration curve dilutions are correct.

Device

VISUDEP-F FROZEN FACTOR XII DEFICIENT PLASMA
  • Modèle / numéro de série
    Model Catalog: FRDP120125 (Lot serial: 0005-12FDP); Model Catalog: FRDP120105 (Lot serial: 0004-12FDP); Model Catalog: FRDP120125 (Lot serial: 0004-12FDP); Model Catalog: FRDP120105 (Lot serial: 0005-12FDP); Model Catalog: FRDP070125 (Lot serial: 0006-7FDP); Model Catalog: FRDP070105 (Lot serial: 0006-7FDP); Model Catalog: FRDP070105 (Lot serial: 0004-7FDP); Model Catalog: FRDP070105 (Lot serial: 0005-7FDP); Model Catalog: FRDP070125 (Lot serial: 0004-7FDP); Model Catalog: FRDP070125 (Lot serial: 0005-7FDP); Model Catalog: FRDP050125 (Lot serial: 0006-5FDP); Model Catalog: FRDP050105 (Lot serial: 0006-5FDP); Model Catalog: FRDP050105 (Lot serial: 0004-5FDP); Model Catalog: FRDP050105 (Lot serial: 0005-5FDP); Model Catalog: FRDP050125 (Lot serial: 0004-5FDP); Model Catalog: FRDP050125 (Lot serial: 0005-5FDP); Model Catalog: FRDP110125 (Lot serial: 0005-11FDP); Model Catalog: FRDP090105 (Lot serial: 0004-9FDP); Model Catalog: FRDP090125 (Lot serial: 0004-9FDP); Model Catalog: FRDP110105 (Lot serial: 0005-11FDP
  • Description du dispositif
    VISUDEP-F FROZEN FACTOR XII DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR VII DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR V DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR XI DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR IX DEFICIENT PLASMA;VISUDEP-F FROZEN FACTOR X DEFICIEN
  • Manufacturer
    AFFINITY BIOLOGICALS INC.

Manufacturer

AFFINITY BIOLOGICALS INC.