Events

Retiro De Equipo (Recall) de RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). 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 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-2014-RN-00702-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-02
  • 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-2014-RN-00702-1
  • 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
    There is an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments. due to this error, the recovery of ph for rapidqc complete, level 2, lot number 362303, is elevated. it is also possible that some instruments may, on occasion, recover ph out of range high. however, the published target ranges for all other analytes are unaffected.
  • Acción
    Siemens is providing their customers with the correct pH range assignments (in pH and H+ units) and corresponding barcodes for all the Siemens blood gas systems. End users are requested to re-enter the corrected pH target ranges, or rescan these barcodes into the blood gas system to replace the ones in the Expected Values Chart and keep this notice with the control material. Repeat testing of any patient samples is at the discretion of laboratory.

Device

RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in ...
  • Modelo / Serial
    RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in vitro diagnostic medical device (IVD).Lot Number 362303ARTG Number: 185171
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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