Events

Retiro De Equipo (Recall) de Streptex Rapid Latex Agglutination Test. 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-2017-RN-01059-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-23
  • 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-2017-RN-01059-1
  • 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 themo fisher has confirmed that extraction enzyme lots 1960420 and1960621 (contained in the product lots 1959920, 1987862 and 2106328) may provide atypical performance when used with streptex g latex reagent. false positive results may be seen within the one minute reaction time detailed in the instruction for use. continued use of these lots of extraction enzyme with g latex reagent (only) may result in incorrect results reporting.
  • Acción
    Users are to inspect stocks and remove from further use all units from the affected batch numbers. Complete the Facsimile Reply Form supplied with the customer letter and fax it to the sponsor for a credit note will be issued. Requirement for a review of patient results should be at the discretion of the laboratory director.

Device

Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)Product Number: R30950501Lot Numbers: 1959920, 1987862 and 2106328ARTG Number: 235676
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand