Events

Retiro De Equipo (Recall) de Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit

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 manufacturer #1479.

¿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
    20108
  • Fecha de inicio del evento
    2016-05-02
  • 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: Abbott Diagnostics, 5440 Patrick Henry Drive, Santa Clara, California 95054, UNITED STATES OF AMERICA
  • Causa
    Manufacturer has identified a potential for increased calibration failures prior to the expiraton date for p specific lots of architect stst high sensitive troponin-1 reagent., cstomers are instructed to either:, 1. once an alternate reagent lot is available the customer is being instructed to destroy remaining inventory of affected list.Or, 2. change the expiration date of impacted lots.
  • Acción
    Product to be destroyed

Device

Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit
  • Modelo / Serial
    Model: 3P25-35 and 3P25-36, Affected: Lot Nos: 59259U100 55957U100 59904U100 and 6207U100
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479