Events

Rappel de Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). 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-2014-RN-01084-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-10-08
  • 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-2014-RN-01084-1
  • 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 has determined that dimension vista mass ckmb isoenzyme calibrator (mmb cal) shows drift during routine stability monitoring that exceeds siemens acceptance criteria for drift over the shelf life of this product. siemens has observed drift from 3% to 12% at mmb concentrations across the assay range. depending on quality control limits, this drift may not have been detected. due to the drift, siemens is revising the expiration date of this product. the manufacturer has confirmed routine stability monitoring data for mmb cal only supports six months. product is labelled for 12 months.
  • Action
    Siemens Healthcare Diagnostics is requesting the customers to discard any remaining inventory of MMB CAL lots and to recalibrate with lot 4FD073 on next calibration. Review of previous testing is at discretion of the laboratory. This action has been closed-out on 04/04/2017.

Device

Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical ...
  • Modèle / numéro de série
    Dimension Vista Systems Mass CKMB Isoenzyme Calibrator (MMB CAL). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10445195Test Code: 0317Catalogue Number: KC672Lot Numbers: 3JD045,4BD064, 4CD012, 4DD065ARTG Number 182776
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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