Events

Retiro De Equipo (Recall) de NucliSENS easyMag Magnetic Silica Mag SIL

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 Biomerieux SA.

¿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
    20575
  • Fecha de inicio del evento
    2016-08-30
  • 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: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Causa
    Following customer complaints about amplification performance issues with the home brew polymerase chain reaction (pcr) and real time pcr assays. the investigation concluded that downstream applications were impacted when the extraction volume was higher than 400 ìl and for double stranded nucleic acids target., double stranded nucleic acid applications with small (< 40kbp) and medium genome sizes (< to 1200 kbp) i.E dna viruses are more impacted than higher human genomic dna and bacterial applications (> to 1200kbp.
  • Acción
    Manufacturer to issue advice regarding use

Device

NucliSENS easyMag Magnetic Silica Mag SIL
  • Modelo / Serial
    Model: , Affected: Z017BB1MS, Z017BF1MS, Z017CC1MS, Z017BA1MS,Z017CG1MS, Z017DC1MS, Z017DD1MS
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA