Events

Retiro De Equipo (Recall) de Amylase Assay used with ADVIA Chemistry Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Ltd Diagnostics Division.

¿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-00340-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-17
  • 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-00340-1
  • 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
    Siemens healthcare diagnostics has confirmed that the affected amylase reagent kit demonstrate an increased incidence of absorbance flags (u or u accompanied by u). absorbance flags (u) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. in some cases with these reagent lots, sample results may also have a sample absorbance (u) flag indicating a high absorbance for the sample that occurs in conjunction with the (u) flag. amylase results can be generated with these flags. the risk to health is limited to a potential delay in amylase testing.
  • Acción
    Siemens is advising users that if a sample (u) flag occurs where there are no absorbance (U) flags, the flag is sample related and the sample should be re-tested. Siemens is advising users who choose not to continue using the affected batches, that Siemens will replace the affected lots. The look back of previously generated results is at the discretion of the laboratory. This action has been closed-out on 07/09/2016.

Device

Amylase Assay used with ADVIA Chemistry Systems
  • Modelo / Serial
    Amylase Assay used with ADVIA Chemistry SystemsTest Code: AMYLASCatalogue Numbers: 07498401 & 03031177Siemens Material Numbers: 10309493 & 10341130Lot Numbers: 304821 & 304816Expiration Date: April 2015 ARTG number: 176331An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA