Events

Retiro De Equipo (Recall) de ZYM B, API Listeria and API NH (bacterial identification reagents and kits). 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-2013-RN-01186-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-14
  • 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-2013-RN-01186-1
  • 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
    Biomérieux identified a visual defect and activity issue on the zym b reagent (reference 70493) which is used as an additional test for revealing the results of some miniaturised biochemical tests. further investigations performed by biomerieux quality control laboratory confirmed an activity issue on zym b reagent. this activity issue lead to a false negative result of some api biochemical tests using the zym b reagent. investigations are still in progress in order to identify the root cause.
  • Acción
    BioMerieux is advising end users to discard any ampoule of ZYM B with a visual defect (as described in the IFU). For units of ZYM B without the visual defect, end users are requested to carry out additional QC when using the potentially affected API kits. If QC fails the kits are to be discarded. Alternatively any kits of ZYM B can be discarded and replaced by bioMerieux.

Device

ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnost...
  • Modelo / Serial
    ZYM B, API Listeria and API NH (bacterial identification reagents and kits). An in vitro diagnostic medical device (IVD)ZYM B reagent (Ref Number: 70493)Multiple lot numbers affectedUsed as an additional test in:- API 20 Strep (Ref Number: 20600)- API Coryne (Ref Number: 20900)- API Staph (Ref Number: 20500)- API ZYM (Ref Number: 25200)API NH (Ref Number: 10400)Multiple lot numbers affectedAPI Listeria (Ref Number: 10300)Multiple lot numbers affected
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd