Events

Retiro De Equipo (Recall) de Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. 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-00628-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-22
  • 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-00628-1
  • 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 ltd, part of thermo fisher scientific, has determined that thermo scientific remel salmonella paratyphi a-h stained suspension (r30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the instructions for use (ifu).
  • Acción
    Thermo Fisher Scientific is requesting users:- Inspect your stocks and remove from further use all units from the affected batch number, then complete the Facsimile Reply Form supplied with the customer letter and fax it to us so that we may arrange for a credit note to be issued. Please complete the Facsimile Reply Form even if you have no remaining stock which is subject to recall, as we require this information to reconcile this process. Any requirement for review of patient results should be determined by the laboratory director.

Device

Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diag...
  • Modelo / Serial
    Thermo Scientific Remel R30855101 - Salmonella paratyphi A-H Stained Suspension. An in vitro diagnostic medical device (IVD)Lot Numbers: 2184561, 2308897, 2228271, 2213610 & 2258333ARTG number: 236824(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs)Possibility of Granularity Upon Dispensing
  • Manufacturer
    Thermo Fisher Scientific Australia & New Zealand

Manufacturer

Thermo Fisher Scientific Australia & New Zealand