Events

Retiro De Equipo (Recall) de Dako EnVision FLEX/HPR reagent

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 DakoCytomation.

¿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
    19174
  • Fecha de inicio del evento
    2015-09-22
  • 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: Global Science a Bio-Strategy Company (Bio-Strategy Limited), 241 Bush Road, Albany, Auckland 0632
  • Causa
    Dako has determined that there is a defect in one lot of a buffer used in the manufacturing of some corresponding lots of the envision™ flex/hrp visualization reagent. specifically, some instances of moderate-to-strong non-specific staining and overly-strong specific staining have been observed when this visualization reagent was used with four antibodies against the biomarkers epstein-barr virus (ebv), mum-1, wilms' tumor1(wt1) protein and smooth muscle actin (sma). negative control antibodies in the same run were negative, and did not show the non-specific staining., , 15/01/2016: subsequent to the earlier letter the remaining dako flex ready-to use antibodies were tested using the affected envision flex/hrp visualization reagent . two additional antibodies wereidentified as having a remote potential to affect results. update overview letter sent.
  • Acción
    Product to be destroyed

Device

Dako EnVision FLEX/HPR reagent
  • Modelo / Serial
    Model: K8000 & K8012, Affected: 20019097 & 20020768
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation