Events

Retiro De Equipo (Recall) de Roche AFB III Staining Kit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por manufacturer #1479.

¿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
    17624
  • Fecha de inicio del evento
    2014-11-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Roche diagnostics has observed a staining artefact on slides stained with the afb iii staining kit. this artefact consists of a circular and a non-specific purple- to pink-coloured slide background staining, which in some cases is present within tissue elements and in other cases takes the form of circular deposits that appear to be above the tissue plane. the latter can occur both within the tissue-containing and blank portions of the slide. this artefact may interfere with the interpretation and identification of acid-fast bacteria, which is the indication for this assay. also, the artefact could be mistaken for acid-fast bacteria and lead to a false positive interpretation. a trained pathologist should recognise the artefacts and reject the slide without attempting to interpret it.
  • Acción
    Product to be destroyed

Device

Roche AFB III Staining Kit
  • Modelo / Serial
    Model: , Affected: Lot Numbers: D05755, D11015, E1024 and E03378
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479