Events

Rappel de ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). 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 Siemens Ltd Diagnostics Division.

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-2015-RN-00598-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-02
  • 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-2015-RN-00598-1
  • 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
    Siemens healthcare diagnostics is issuing a field correction for a change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia chemistry systems acetaminophen assay current lots and all future lots. the previous maximum nac concentration at which acceptable acetaminophen results were obtained was 800 mg/l. siemens has revised the concentration of nac at which acceptable results were obtained to 200 mg/l nac in an acetaminophen sample of approximately 661 µmol/l (10 mg/dl).
  • Action
    Siemens is advising end users of the change in the instructions for use regarding interference caused by NAC. The Instructions For Use (IFU) will be updated to reflect this change in interference.

Device

ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical de...
  • Modèle / numéro de série
    ADVIA Chemistry Systems - Acetaminophen N-acetylcysteine (NAC). An in vitro diagnostic medical device (IVD).Catalogue/Lot number – SMN 10327381, all current lots (see below) and all future lotsCurrent lots - 46251, 46564, 46369, 46370, 46619, 46782, 47001, 47157, 47558ARTG Number: 176646
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA