Events

Retiro De Equipo (Recall) de Synchron Systems Microalbumin (MA) Reagent

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter 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-2017-RN-00627-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-15
  • 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-00627-1
  • 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
    Beckman coulter has confirmed that ma reagent lot m609458 may recover outside the lower limit of the published insert range for beckman coulter urine protein control level 1. internal testing has confirmed that ma is recovering within the published insert range for beckman coulter urine protein control level 2.As a result, patient results with ma reagent lot m609458 may be up to 0.5 mg/dl lower than actual values. in addition, lower recovery of ma in urine protein control level 1 may cause ma to exceed the lower limits of a laboratory's established qc range.
  • Acción
    Beckman Coulter is advising users to discontinue use and discard MA Reagent Lot M609458 following their laboratory's disposal protocol. Replacement product will be provided.

Device

Synchron Systems Microalbumin (MA) Reagent
  • Modelo / Serial
    Synchron Systems Microalbumin (MA) Reagent Reference Number: 475100Lot Number: M609458Expiry Date: 30 Sep 2018ARTG Number: 213984
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd