Events

Retiro De Equipo (Recall) de REAGENT RED BLOOD CELLS ORTHO 0.8% SURGISCREEN

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL DIAGNOSTICS.

¿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
    77182
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-08-19
  • 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
    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
  • Modelo / Serial
    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)
  • Descripción del producto
    Reagent Red Blood Cells 0.8% SURGISCREEN
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS