Events

Retiro De Equipo (Recall) de AcroMetrix PeliSpy Sero Control Type 36 and Type 38. 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 Life Technologies Australia 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-2013-RN-00084-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-30
  • 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-2013-RN-00084-2
  • 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
    The manufacturer of pelispy sero control type 36 and type 38 advises that affected lots may produce signal to cut-off (s/co) ratios <1 when run on the prism hbsag assay. consequently, if these lots are implemented as a go-no-go control using a threshold s/co ratio of 1 in the prism hbsag assay, test runs may need to be failed.
  • Acción
    Life Technologies is requesting users to inspect and quarantine any affected lots. Arrangements for stock recovery and replacement will be arranged upon confirmation of affected units.

Device

AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    AcroMetrix PeliSpy Sero Control Type 36 and Type 38. An in vitro diagnostic medical device (IVD)Type 36Catalogue number: 964608 and S2381Lot numbers: 201305 (Expiry date: 01/2014) and 035717 (Expiry date: 03/2013) Type 38Catalogue number : 964609 and S2404Lot numbers : 035716 (Expiry date: 01/2014) and 220905 (Expiry date: 08/2014)ARTG Number: 192532
  • Manufacturer
    Life Technologies Australia Pty Ltd

Manufacturer

Life Technologies Australia Pty Ltd