Events

Retiro De Equipo (Recall) de Panthera-Puncher 9, An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por PerkinElmer.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00714-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00714-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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