Events

Rappel de Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomerieux Australia Pty Ltd.

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
    RC-2017-RN-00224-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-02-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00224-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    In july 2016 customers were informed about a decrease of extraction performances for some specific downstream applications with 7 batches of magsil, which can lead to a risk of false negative, invalid or under-quantification results (tga ref.: rc-2016-rn-00949-1). following this action, biomérieux put in place several additional quality controls (qc) at the release of batches. the released batches performances have been monitored in real-time for stability. as a result, in jan 2017 customers were informed that the issue may affect a further 8 magsil batches (tga ref.: rc-2016-rn-01551-1).The corrective actions provided for the batches under rc-2016-rn-01551-1 remain appropriate. for the 7 batches included in the july 2017 action, a drift of the performance results was observed after a few months of release with the biomérieux bk-virus r-gene test. since one biomérieux assay is impacted, the usability of these batches with all biomérieux applications cannot be assured.
  • Action
    bioMérieux is advising customers to quarantine the remaining kit from lots Z017BB1MS, Z017BF1MS, Z017BA1MS, Z017CC1MS, Z017CG1MS, Z017DC1MS & Z017DD1MS. bioMérieux will arrange for the return of these kits and also credit/replacement. Any concerns regarding previously reported results should be discussed with the Laboratory Director to determine the appropriate course of action.

Device

Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/...
  • Modèle / numéro de série
    Magnetic Silica MagSIL. An in vitro diagnostic medical device (IVD).(used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)Lot Numbers:Z017BB1MS, Z017BF1MS, Z017BA1MS Expiry Date: 28/02/2017Z017CC1MS, Z017CG1MS Expiry Date: 28/03/2017Z017DC1MS, Z017DD1MSExpiry Date: 28/04/2017ARTG Number: 240760
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd