Retiro De Equipo (Recall) de Various Microgenics Applications Sheets. 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 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
  • 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
    It has been determined that application sheets provided by the manufacturer microgenics for expanded use of some assays are inadequate. specifically, the appropriate validation data for the expanded use of these assays, as indicated in the instructions for use (ifu) when not used on manufacturer approved analysers, is inadequate. in addition, microgenics did not clearly state in these application sheets that the parameters provided are only to be used as starting points and that each assay setting needs to be validated individually by the user.Thus the information given on the specific application sheets for use with non-microgenics approved analysers may be ineffective. it is possible that assays not validated for use with other instrument platforms could potentially lead to erroneously low or high test results.
  • Acción
    Beckman Coulter is requesting Customers: 1. Immediately check if they are using any of the affected Application Sheets on the platforms as listed in the letter supplied; and 2. Discontinue use of the affected Application Sheets. Review their internal assay validations to determine if the current instrument settings using these Assays require additional action within the clinical laboratory setting. If customers have performed a compliant self-validation of a particular Assay on a specific instrument in accordance with applicable laboratory certifications or requirements, they may be able to continue to use that Assay on the corresponding instrument. Consult a qualified healthcare professional as appropriate. If they have performed a compliant self-validation, note that on the supplied Vigilance Response Form.


  • Modelo / Serial
    Various Microgenics Applications Sheets. An in vitro diagnostic medical device (IVD)Multiple Assays / Instrument PlatformsAll LotsARTG Numbers 274335 and 275701
  • Manufacturer