Events

Rappel de Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay 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 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-00874-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • 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-00874-1
  • 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 received complaints for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista chem 1 cal lot 3gm081. investigation by siemens confirms that qc and patient samples show low recovery of mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • Action
    CHEM 1 CAL lot 3GM081 expired on 1 July 2014; however, Siemens is advising their customers to immediately calibrate MG with an alternate lot of CHEM 1 CAL if a calibration of MG with this lot of CHEM 1 CAL is still active. Siemens recommends that the content of this letter and review of previous testing should be discussed with your Medical Director. This action has been closed-out on 03/06/2016.

Device

Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro ...
  • Modèle / numéro de série
    Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro diagnostic medical device (IVD).Catalogue Number: KC110Siemens Material Number: 10445169Lot Number: 3GM081ARTG number: 182222
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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