Events

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

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-2016-RN-01551-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-01-25
  • 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-2016-RN-01551-1
  • 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 specific batches of magnetic silica (magsil). the investigation concluded that downstream applications were impacted when the extraction volume was higher than 400µl 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). the decrease of downstream application performances can lead to a risk of false negative, invalid or under-quantification results. if invalid results are obtained, it could lead to a delayed result until a new run or a new extraction is performed. since, biomérieux has identified subsequent batches that may be affected.
  • Action
    bioMérieux is advising users to ensure controls with the same nature/structure as the target and/or external controls are used to detect the issue. Users are advised to reduce the sample input volume to 200µL until the silica problems is resolved. Downstream ARGENE and NucliSENS easyQ HIV 1 V2.0 applications performed according to the IFU are not affected. It is recommended that the continued use with blood transfusion testing is confirmed by the Laboratory Director, and to discuss any concerns regarding previously reported results with the Laboratory Director.

Device

Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for autom...
  • Modèle / numéro de série
    Magnetic Silica MagSIL (used with NucliSENS easyMAG/eMAG nucleic acid extraction system for automated extraction of total nucleic acids (RNA/DNA) from biological samples)An in vitro diagnostic medical device (IVD)Catalogue Number: 280133Lot Numbers: Z017KA1MS, Z017KB1MS (Expiry: 28/09/2017)Z017LE1MS (Expiry: 28/10/2017)Z017MA1MS (Expiry: 28/11/2017)Z017NA1MS, Z017NB1MS, Z017NC1MS, Z017ND1MS (Expiry: 28/12/2017)ARTG Number: 240760
  • Classification du dispositif
    Hematology and Pathology Devices
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd