Events

Retiro De Equipo (Recall) de Cobas modular analytic series system

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 Patheon API 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
    21590
  • Fecha de inicio del evento
    2017-06-28
  • 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: Roche Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Causa
    In very rare cases when a number of specific conditions are met, it is possible that a sample mismatch may occur in the immunochemistry modules (cobas e 602, cobas e 601 and e170 modules) due to a software limitation. if the gripper fails to pick up a sample vessel (cup) for a sample on the rack being assayed, the measurement for that sample is cancelled and the warning "tip/cup pick up error" (caution level) is issued.
  • Acción
    Product to be modified

Device

Cobas modular analytic series system
  • Modelo / Serial
    Model: , Affected: Immunochemistry module cobas e 602, cobas e 601 and E170 modules, cobas 8000 modular analyzer series, cobas 6000 analyzer series, MODULAR ANALYTICS, MODULAR ANALYTICS EVO
  • Manufacturer
    Patheon API Inc.

Manufacturer

Patheon API Inc.