Events

Rappel de NucliSENS easyMag Magnetic Silica Mag SIL

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Biomerieux SA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    20575
  • Date de mise en oeuvre de l'événement
    2016-08-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Cause
    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.
  • Action
    Manufacturer to issue advice regarding use

Device

NucliSENS easyMag Magnetic Silica Mag SIL
  • Modèle / numéro de série
    Model: , Affected: Z017BB1MS, Z017BF1MS, Z017CC1MS, Z017BA1MS,Z017CG1MS, Z017DC1MS, Z017DD1MS
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA