Events

Retiro De Equipo (Recall) de Ortho Clinical Diagnostics BioVue System Cassettes

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 Ortho-Clinical Diagnostics European Support Centre.

¿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
    15059
  • Fecha de inicio del evento
    2013-08-08
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Causa
    Ortho clinical diagnostics (ocd) has identified isolated occurrences of improperly positioned cassette labels for the products specified. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection results. there is no risk associated with the use of an affected single-reagent cassette since all wells contain the same reagent.
  • Acción
    Product to be exchanged

Device

Ortho Clinical Diagnostics BioVue System Cassettes
  • Modelo / Serial
    Model: BioVue ABD confirmation Cassette, VioVue Rh/K Cassette, BioVue ABO-DD Grouping Cassette, BioVue ABO-Rh Grouping Cassette, BioVue Poly/Neutral Cassette, Affected: Lots: 6904485 and 707135
  • Manufacturer
    Ortho-Clinical Diagnostics European Support Centre

Manufacturer

Ortho-Clinical Diagnostics European Support Centre