Retiro De Equipo (Recall) de Trinity Biotech Captia Cytomegalovirus (CMV) IgG

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Trinity Biotech.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Banksia Scientific Pty Ltd (NZ), 12 Brigade Street, Airport Oaks, Auckland
  • Causa
    Upon review of the qa release testing, the range that was calculated at the time of kit release was calculated per standard operating procedures and supports the positive control range that was assigned upon release of 2.2-4.1., however, upon investigation of history (as a positive control in several kit lots) and additional testing it has been re-evaluated and determined that this range requires an adjustment to 2.2-4.6., if you have used this kit lot to test and report patient results, and the positive control was within the assigned range (2.2-4.1), then the reported patient results were valid.
  • Acción
    Instructions for use to be updated


  • Modelo / Serial
    Model: Product Code: 2325200, Affected: Lot Number: 557
  • Manufacturer