Events

Retiro De Equipo (Recall) de Epoc BGEM Test Cart

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 Epocal 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
    14449
  • Fecha de inicio del evento
    2013-04-03
  • 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: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
  • Causa
    Affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of glucose test sensor. specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 - 30 % has been observed in sample with glucose levels greater than 22 mmol/l.
  • Acción
    Product to be destroyed

Device

Epoc BGEM Test Cart
  • Modelo / Serial
    Model: Catalogue No.: CT-1004-00-00, Affected: Lot: 07-12289-00, 07-12363-00
  • Manufacturer
    Epocal Inc

Manufacturer

Epocal Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA