Events

Retiro De Equipo (Recall) de Vitros Performance verifier 1

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
    18611
  • Fecha de inicio del evento
    2015-06-03
  • 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: Ortho-Clinical Diagnostics c/- Johnson & Johnson, 13A Gabador Place, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has observed a positive bias with the first slide used from a cartridge that has been stored in the slide supply. the bias has been observed with multiple fluids across multiple gens and coating of slides and across the 5,1.Fs, 4600 amd 5600 analyzer platforms. the frist slide bias may occur when a cartridge is loaded on an analyzer and is not used for approximately 5-14 days., ocd has revised the range of means for vitros performance verifier1 for unconjugated biirubin (bu) only.
  • Acción
    Manufacturer to issue advice regarding use

Device

Vitros Performance verifier 1
  • Modelo / Serial
    Model: 8067324, Affected: Lot Numbers: A3823 C4084 Q2961 T3161 V3297 and X3569
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479