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
    86169
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-11-05
  • 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
    When results of "---.-" are received from the sysmex uf-100 instrument and if the user set the driver configuration option "strip zeros from result" to "yes" all versions prior to v7.00.0006 and v8.00.0005 of the sysu100i driver convert the results to "0.00" in instrument manager. the sysmex uf-100 will send "--.-" when the test has a sample error. all five urinalysis tests performed (rbc wbc ec cast and bact) will be resulted as "0.00" in instrument manager. this could lead to misdiagnosis and mistreatment of a patient.

Device

INSTRUMENT MANAGER
  • Modelo / Serial
    Model Catalog: 8.00.0003 (Lot serial: Not applicable); Model Catalog: 8.00.0002 (Lot serial: Not applicable); Model Catalog: 8.00.0004 (Lot serial: Not applicable); Model Catalog: 7.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0002 (Lot serial: Not applicable); Model Catalog: 7.00.0003 (Lot serial: Not applicable); Model Catalog: 7.00.0005 (Lot serial: Not applicable); Model Catalog: 8.00.0001 (Lot serial: Not applicable); Model Catalog: 7.00.0004 (Lot serial: Not applicable)
  • Descripción del producto
    Instrument Manager Software using the sysu100i driver that connects to the Sysmex UF-100 instrument
  • Manufacturer
    DATA INNOVATIONS LLC

Manufacturer

DATA INNOVATIONS LLC