Events

Retiro De Equipo (Recall) de ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    35655
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-15
  • 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
    Iris international has confirmed the ichemvelocity automated urine chemistry system does not maintain the on-board strip stability of 5 days at 18-28 degrees c at 20-80% relative humidity (rh) as stated in the ichemvelocity product labeling. the on-board strip stability is affected by temperature and humidity in the laboratory. if a laboratory operates outside of the parameters defined in table 1 of the urgent medical device recall letter test results may be affected as indicated below: - false low or false negative results: ketone blood - false high or false positive results: bilirubin glucose leukocytes - false high results: urobilinogen ascorbic acid protein ph and nitrite are not affected.

Device

ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD
  • Modelo / Serial
    Model Catalog: 800-7167 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 800-7719 (Lot serial: V03266); Model Catalog: 800-7719 (Lot serial: V03263); Model Catalog: 800-7719 (Lot serial: V02850); Model Catalog: 800-7719 (Lot serial: V01384); Model Catalog: 800-7719 (Lot serial: V02800); Model Catalog: 800-7719 (Lot serial: V02781); Model Catalog: 800-7719 (Lot serial: V03301); Model Catalog: 800-7719 (Lot serial: V02564)
  • Descripción del producto
    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W/LOAD/UNLOAD
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC