Events

Rappel de Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs)

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-2013-RN-00153-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-02-18
  • 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-2013-RN-00153-1
  • 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 have confirmed customer complaints of falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent. the inaccurate ezcr results are caused by a reagent interaction that occurs when vapour from phos reagent is absorbed by open wells of the excr flex reagent cartridge. both quality control (qc) samples and patient samples are affected.
  • Action
    If both Enzymatic Creatinine and Phosphorus are tested using the instrument, customers are requested to discontinue the use of one of the tests. Customers with two or more Dimension systems should perform testing of Enzymatic Creatinine and Phosphorus on separate instruments. This action has been closed-out on 12/02/2016.

Device

Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for...
  • Modèle / numéro de série
    Enzymatic Creatinine (EZCR) Flex Reagent Cartridge & Phosphorus (PHOS) Flex Reagent Cartridge for use on the Dimension Clinical Chemistry System. In vitro diagnostic medical devices (IVDs)PHOS Flex Reagent CartridgeCatalogue Number: DF61Material Number: 10444951EZCR Flex Reagent CartridgeCatalogue Number: DF270BMaterial Number: 10471520ARTG Number: 181686
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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