Events

Rappel de Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMP

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-2015-RN-00961-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-25
  • 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-00961-1
  • 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
    The reagent kit lots listed above demonstrate an increased incidence of absorbance flags (u, u) and //// errors. absorbance flags u and u indicate abnormal high absorbance exceeding either the blank or sample limit. absorbance flag //// indicates a calculation error and no result is generated by the system.The increased rate of absorbance flags with these lots has not been associated with inaccurate results. if calibration and quality control results are acceptable, reported patient results are acceptable. this risk to health is negligible. siemens advises the potential for clinical impact and overall risk to health as a result of this issue is negligible.
  • Action
    Customers are asked to quarantine affected units from use prior to destruction and/or disposal.

Device

Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XP...
  • Modèle / numéro de série
    Alkaline Phosphatase (ALPAMP, ALPDEA and ALPA_c) used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems Alkaline Phosphatase ALPAMPCatalogue Number: 03035814Lot Number: 327460Alkaline Phosphatase ALPDEACatalogue Number: 03036535Lot Number: 327465 Alkaline Phosphatase Concentrated ALPA_cCatalogue Number: 06860450Lot Number: 327471ARTG Number: 176331
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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