Events

Retiro De Equipo (Recall) de VISUDEP-F FROZEN FACTOR XII DEFICIENT PLASMA

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por AFFINITY BIOLOGICALS INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    60723
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-08-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    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
  • Descripción del producto
    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.