Events

Rappel de Panthera-Puncher 9, 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 PerkinElmer.

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-00714-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-07-03
  • 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-00714-1
  • 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
    Wallac oy, a subsidiary of perkinelmer, has become aware that extended exposure to the ioniser pins of the panthera-puncher 9 can decrease the reaction signal level of assays using antibody coated microtiter plates (such as immunoassays). wallac oy's investigation has shown that uncoated plates are not affected by the phenomenon (such as enzymatic assays). the phenomenon has been determined to be localised to those wells that are located beneath or adjacent to the ioniser pins when the panthera-puncher 9 is idle or in sleep mode. the software allows the ioniser to remain active when the puncher is idle or has gone into sleep mode. the impact on health is dependant on the assay and the associated disorder the assay screens for in the dried blood spot sample.
  • Action
    PerkinElmer is advising end users to remove plates from the Panthera-Puncher 9 when not actively punching and processing samples. If plates must reside in the device the plate track hatch should be opened to disrupt power to the ioniser. A PerkinElmer Representative will contact customers to arrange for inspection. Additionally, a software update is under development that will automatically switch off the ioniser when the device is in idle. This action has been closed on 29/01/2016.

Device

Panthera-Puncher 9, An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    Panthera-Puncher 9, An in vitro diagnostic medical device (IVD)Catalogue Number: 2081-0010Serial Numbers: 20810043, 20810139 and 20810145ARTG Number: 186748
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer