Events

Retiro De Equipo (Recall) de Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems

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 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
    19634
  • Fecha de inicio del evento
    2016-11-28
  • 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
    Manufacturer has initiated a recall due to the need to clarify operator actions folloing u90-382 or 6lu cnditions codes generated by the system., if a u90-382 or 6lu condition code (i.E associated with a wash error) occurs, the condition code text located on the vitro system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios., this notification provides additional information to a product correction notification that ortho clinical diagnostics (ortho) issued in december 2015 (medsafe ref. 19634) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors. we observed an increase in wash errors for vitros chemistry products phyt slides.
  • Acción
    Manufacturer to issue advice regarding use

Device

Ortho-Clinical Diagnostics Vitros 350 Chemistry Systems

Manufacturer

Ortho-Clinical Diagnostics Inc