Events

Retiro De Equipo (Recall) de SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)

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

¿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-01176-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-11-28
  • 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-01176-1
  • 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
    Fertipro has informed that some customers have reported reduced motility in certain semen samples when using the updated spermmar iga test (brown beads). this reduced motility may result in a lower proportion of free moving sperm and affect the interpretation of the results.
  • Acción
    Customers are instructed to stop using and destroy the affected batches. Fertipro is currently working on optimising the buffer of the reagent to avoid this reduction in motility. The optimised reagent will be included from batch FP14A11 onwards. Users are advised that the need for a look back at previously reported results be discussed with their clinical/laboratory director. This action has been closed-out on 01/03/2016.

Device

SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)
  • Modelo / Serial
    SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA) BatchNumber: FP14A09, FP14A10An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA