Events

Retiro De Equipo (Recall) de API ZYM B. 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 Biomerieux 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-2015-RN-01270-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-24
  • 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-2015-RN-01270-1
  • 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
    Based on discrepant results (false negative results) reported from the field, biomérieux initiated a complaint investigation to confirm product performance and determine root cause. the investigation confirmed a loss of performance after 3 months of shelf life for api zym b, which led to false negative results on some api strips using the zym b reagent. as a result of the zym b performance shift, the risk is to potentially report a false negative result of some api tests; misidentification of some species with api 20 strep, api nh, api listeria and api coryne. api staph is not impacted by a risk of misidentification. regarding api zym, as it is designed for the research of enzymatic activities, there is no risk of microorganism misidentification.
  • Acción
    Biomerieux is advising users to perform quality control with ATCC strains prior to using the ZYM B ampule. A review of previously reported results is recommended at the discretion of the Laboratory Director.

Device

API ZYM B. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    API ZYM B. An in vitro diagnostic medical device (IVD)Product Code: 70493Multiple Lot numbers affectedARTG Number: 232822
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd