Events

Retiro De Equipo (Recall) de INSTRUMENT MANAGER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DATA INNOVATIONS LLC.

¿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
    132851
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-06-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Quality control (qc) results without a qc specimen id (sid) are being filed with patient results that follow it in the same message on instrument manager siemens dpc cirrus lmmulite/lmmulite/versacell (dpcimmui) driver. if the cirrus lmmulite lmmulite one lmmulite 1000 lmmulite 2000 lmmulite 2500 or lmmulite xpi instrument is running in uni-directional mode and is configured to automatically send qc results to the laboratory information system (lis) and specimen ids are not added to qc samples then qc results received by im without a specimen id will be added to the first specimen received after these qc results in the same astm message.

Device

INSTRUMENT MANAGER
  • Modelo / Serial
    Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0021); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0020); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0019); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0018); Model Catalog: VX.XX.XX (Lot serial: driver version 8.00.0017)
  • Descripción del producto
    Instrument Manager
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC