Events

Retiro De Equipo (Recall) de Wallac Panthera-Puncher 9

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand 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
    16956
  • Fecha de inicio del evento
    2014-07-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: SciMed Ltd, Unit 2, 1 Tussock Lane, Ferrymead, Christchurch 8023
  • 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 dependent on the assay and the associated disorder the assay screens for in the dried blood spot sample.
  • Acción
    Product to be modified

Device

Wallac Panthera-Puncher 9
  • Modelo / Serial
    Model: Catalogue Number: 2081-0010, Affected:
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer