Events

Rappel de ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). 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 Healthcare 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-00247-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-21
  • 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-00247-1
  • 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 providing an update to all advia chemistry systems lactate dehydrogenase l-p (ldlp) and lactate dehydrogenase p-l (ldpl) assay instructions for use (ifu). the current intended use section within in the advia chemistry systems lactate dehydrogenase ifu document contains the following statements which will be removed (given these assays are not validated to monitor for cancer therapy):"advia chemistry ldlp: they may also be used to monitor cancer therapy.Advia chemistry ldpl: they may also be used to monitor extensive cancer and cancer therapy.".
  • Action
    Siemens is advising users to refer to the revised intended use statement in the notification in order to use the assays as defined. Users will be provided with the updated IFU when it becomes available.

Device

ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).
  • Modèle / numéro de série
    ADVIA Chemistry Lactate Dehydrogenase (LDLP and LDPL). An in vitro diagnostic medical device (IVD).ADVIA Chemistry Lactate Dehydrogenase L-PTest Code: LDLPReference Numbers: 07502115 (40 mL) & 03029628 (70 mL)Siemens Material Numbers: 10309501 (40mL) & 10341128 (70 mL)ADVIA Chemistry Lactate Dehydrogenase P-LTest Code: LDPLReference Numbers: 07502999 (40 mL) & 03030863 (70 mL)Siemens Material Numbers: 10309502 (40 mL) & 10341129 (70 mL)All LotsARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA