Retiro De Equipo (Recall) de N Latex ß2–Microglobulin

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 Healthcare 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 received complaints from customers not being able to establish a calibration curve or to validate an established calibration curve with the respective controls when using one of the affected lots of n latex ß2-microglobulin. the issue might lead to the inability to calibrate the assay or to obtain invalid test runs. however, patient results are not affected. there is the potential for the user to be exposed to assay components contaminated with pseudomonas libanensis, pseudomonas rhodesiae and pseudomonas extremorientalis. exposure may lead to an infection and its consequencesa review of previously generated results due to this issue is at the discretion of the laboratory.Siemens advises that the delay of results for these assays does not represent a hazard, and as a result the severity level is none or negligible.
  • Acción
    Customers are asked to discontinue use of and discard the affected lots listed in the Customer Letter. A replacement or credit will be issued as per the normal procedure.


  • Modelo / Serial
    N Latex ß2–Microglobulin Catalogue Numbers: OQWU155 and OQWU15 Lot Numbers: 44862, 44902, 44968, 45192, 45229, 45252, 45291, 45329, 45342, 45366, 45470, 45525 and 45543. ARTG Number: 178153
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source