Events

Retiro De Equipo (Recall) de HEMOCUE GLUCOSE 201 SYSTEM - MICROCUVETTES

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

¿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
    38621
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-05-23
  • 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
    Manufacturer has revised user manual to indicate that glucose readings for preterm neonate (>37 weeks) be verified against laboratory reference methods since the readings may be unreliable.

Device

HEMOCUE GLUCOSE 201 SYSTEM - MICROCUVETTES
  • Modelo / Serial
    Model Catalog: 110706 (Lot serial: with article #s 110706 110705); Model Catalog: 110705 (Lot serial: all unexpired microcuvettes); Model Catalog: 110705 (Lot serial: with article #s 110706 110705); Model Catalog: 110706 (Lot serial: all unexpired microcuvettes); Model Catalog: 110402 (Lot serial: ); Model Catalog: 120402 (Lot serial: all analyzers with article #s); Model Catalog: 120413-2 (Lot serial: all analyzers with article #s); Model Catalog: 110402 (Lot serial: all analyzers with article #s); Model Catalog: 120402 (Lot serial: 120402 120413-2); Model Catalog: 120413-2 (Lot serial: ); Model Catalog: 120402 (Lot serial: ); Model Catalog: 110402 (Lot serial: with article #s 110402); Model Catalog: 120413-2 (Lot serial: with article #s 110402); Model Catalog: 120402 (Lot serial: with article #s 110402); Model Catalog: 110402 (Lot serial: all unexpired microcuvettes); Model Catalog: 120413-2 (Lot serial: all unexpired microcuvettes); Model Catalog: 120402 (Lot serial: all unexpired microcuvettes); Model Ca
  • Descripción del producto
    Hemocue Glucose 201 System Microcuvette
  • Manufacturer
    HEMOCUE AB

Manufacturer

HEMOCUE AB