Retiro De Equipo (Recall) de Innovance D-Dimer assay run on Sysmex CS Systems. 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-2017-RN-00112-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-23
  • País del evento
  • Fuente del evento
    DHTGA
  • 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 confirmed that under very rare circumstances a false negative result may be reportable. the issue may only occur under the following conditions:- the initial result is falsely flagged with an antigen excess error that triggers an automatic reanalysis in a 1/19 dilution; and- the raw signal that is generated from the reanalysis is below the limit of blank (lob) of the method.Under such conditions the low reanalysis raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low optical raw value. this raw value is corrected by the dilution factor and can then be incorrectly calculated from the calibration curve as a falsely low result.
  • Acción
    Siemens is advising customers that the threshold for “Min Range” of the extrapolation needs to be changed within the Innovance D-Dimer assay setting on the Sysmex system as follows: - In the CS software, Select “Menu” - Select “Settings” - Select “Assay Group Settings” - Select “Innovance D-dimer” assay - Double click assay parameter “INN DDi” - Under the “Calculation Method” tab, change the current “Extrapolation” threshold for the “Min” extrapolation range from 0.01 to the new threshold of 1.00 - Select “Save” and restart CS-System software After the restart, the system will work with the new setting. Siemens is also recommending that laboratories discuss the customer letter with their Medical Director and consider the need for a look-back of previously generated results that may be affected by this issue.

Device

  • Modelo / Serial
    Innovance D-Dimer assay run on Sysmex CS Systems. An in vitro diagnostic medical device (IVD).Sysmex CS-2000iSiemens Material Number: 10488064Sysmex CS-2100iSiemens Material Number: 10488062Sysmex CS-2500Siemens Material Number: 11239235Sysmex CS-5100 Siemens Material Number: 10709128ARTG Number: 179939
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA