Events

Rappel de PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. 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-00678-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-26
  • 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-00678-1
  • 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 has confirmed a negative bias of approximately -20% for results obtained with dimension vista cer flex reagent cartridge when calibrating cer with specific prot 1 cal lots. prot 1 controls for cer are similarly biased. a deviation in the value assignment of the affected calibrators and controls is leading to a lower result compared to correctly assigned calibrators. patient samples with a true ceruloplasmin value of up to +20% above the lower end of the reference interval may be incorrectly found below the reference interval.
  • Action
    Siemens has assigned correct values to those lots of calibrators and controls where sufficient material was available for a new value assignment. Siemens is providing users with the correct values for these lots and advising users that these lots can be used for determination of ceruloplasmin with the revised assigned values and acceptance ranges. Lots for which revised values have not been provided are not to be used for ceruloplasmin measurements. The customer letter is to be reviewed with the laboratory Medical Director.

Device

PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro ...
  • Modèle / numéro de série
    PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)PROT 1 CALProduct Code: KC710SMN: 10469516PROT 1 CON LProduct Code: KC715SMN: 10445919PROT 1 CON MProduct Code: KC716SMN: 10445920PROT 1 CON HProduct Code: KC717SMN: 10445921Multiple Lot NumbersARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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