Events

Retiro De Equipo (Recall) de Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. 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 Thermo Fisher Scientific Australia & New Zealand.

¿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-2018-RN-00201-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-20
  • 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-2018-RN-00201-1
  • 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
    An internal technical investigation by remel europe, part of thermo fisher scientific, has confirmed that remel neisseria meningitidis poly a-d (r30166601) and neisseria meningitidis group d (r30167001) may fail to agglutinate within the specified minimum reaction time when tested with group d neisseria meningitidis bacteria. continued use of these lots may result in a failure to correctly identify isolates as group d neisseria meningitidis bacteria. the product thermo scientific remel neisseria meningitidis poly a-d (r30166601) continues to correctly identify neisseria meningitidis groups a, b and c. no other batches or pack sizes of this product are affected by this recall.
  • Acción
    ThermoFisher is advising users to inspect stock and remove all units of the affected batches from further use. Users should complete the Facsimile Reply Form provided with the Customer Letter to arrange for a credit note to be issued.

Device

Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2m...
  • Modelo / Serial
    Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. An in vitro diagnostic medical device (IVD)Catalogue Numbers: R30166601, R30167001Lot Numbers: 2239498, 2177820, 2239861, 1773410 & 1739963. ARTG Number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand