Events

Rappel de ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. 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 Roche Diagnostics Australia Pty Limited.

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-00712-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-26
  • 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-00712-1
  • 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
    Investigations by roche have confirmed an increase in native patient sample result recovery of approximately 15 – 20% when using certain lot combinations of online tdm gentamicin with preciset tdm i calibrator. a combination with tdm control set lot 125783 does not show this effect. this may result in sub therapeutic serum levels of gentamicin leading to a delay in treatment and potentially leading to the spread of infections.
  • Action
    Roche is advising users to immediately stop using ONLINE TDM Gentamicin reagent until further notice. Stock does not need to be discarded at this time. Users may continue to use the Preciset TDM I Calibrator for all other TDM assays on cobas c modules and MODULAR ANALYTICS (except for GENT2) and for all TDM (including GENTM) on COBAS INTEGRA systems. This action has been closed-out on 15/02/2017.

Device

ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device ...
  • Modèle / numéro de série
    ONLINE TDM Gentamicin assay and Preciest TDM I Calibrator. An in vitro diagnostic medical device (IVD)ONLINE TDM Gentamicin, 100 testsMaterial Number: 04490843190Lot Numbers: 119166, 611780, 617623ONLINE TDM Gentamicin, 100 testsMaterial Number: 05841291190Lot Numbers: 119167, 611783, 617624Preciset TDM I CalibratorMaterial Number: 03375790190Lot Numbers: 615118, 619681, 126387, 140735ARTG Number: 174910
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited