Events

Retiro De Equipo (Recall) de Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 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 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
    Recall
  • ID del evento
    RC-2016-RN-01237-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-22
  • 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-2016-RN-01237-1
  • 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 identified that certain lots of aqc have been incorrectly value assigned resulting in a +8 g/l bias for level 1 thb on rapidpoint 400/405/500 systems. some users are reporting higher than expected results for this aqc level. since the mis-assigned value is within the allowable range, there are no error flags. customers who use rilibak ranges or have tightened the aqc ranges may see a failed aqc error code.
  • Acción
    Siemens is advising users that if the Quality Control values are recovering within range, users may continue to use the current stock of AQC cartridges that they have from these lots. For users experiencing tHb running high for AQC Level 1, a suggested workaround is to reset the target tHb value for Level 1 as 188 g/L, while using the impacted cartridges. Siemens is recommending users review the letter with their Medical Director.

Device

Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro di...
  • Modelo / Serial
    Automatic QC Cartridge tHb Level 1 (used with RAPIDPoint 400/405/500 instruments). An in vitro diagnostic medical device (IVD)Siemens Material Number: 10310323Lot Numbers: AQC/19516, AQC/19616, AQC/20816, AQC/20916, AQC/21016, AQC/21416, AQC/21516ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA