Events

Retiro De Equipo (Recall) de PANOCELL-10 FICIN TREATED REAGENT RED BLOOD CELLS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por IMMUCOR 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
    16127
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-11-19
  • 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
    Immucor inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a market withdrawal of cell 4 included in the panocell-10 ficin-treated lot 38324-e. cell 4 (donord1377) on this panel is listed as s+s- on the master list. in response to a report of unexpected negative reactivity on untreated cell 4 we have reproduced the customer's reported results. cell 4 has demonstrated reactivity varying from negative to 3+ using different sources of anti-s. cell 4 is one of four s+ red blood cells on this panel: cells 2 7 and 9 are also s+. cell 4 is the only s+s- cell on this panel.

Device

PANOCELL-10 FICIN TREATED REAGENT RED BLOOD CELLS
  • Modelo / Serial
    Model Catalog: 0002385 (Lot serial: 38324-E)
  • Descripción del producto
    Panocell-10 Ficin-Treated
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Dirección del fabricante
    NORCROSS
  • Empresa matriz del fabricante (2017)
    Ivd Holdings Inc
  • Source
    HC