Events

Retiro De Equipo (Recall) de COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER

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

¿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
    23772
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-04
  • 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
    The manufacturer has identified during internal investigation following customer injury complaints that a new mandatory cleaning procedure for sample rack trays was required to mitigate the risk of > potential user injury.

Device

COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
  • Modelo / Serial
    Model Catalog: 06390498001 (Lot serial: More than 100 contact manuf.); Model Catalog: 07649142001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04745922001 (Lot serial: More than 100 contact manuf.); Model Catalog: 28122474001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05964067001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03051323001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05990378001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05412722001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05524245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 06473245001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05641489001 (Lot serial: More than 100 contact manuf.); Model Catalog: 04775201001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05082579001 (Lot serial: More than 100 contact manuf.); Model Catalog: 05083435001 (Lot serial: More than 100 contact manuf.); Model Catalog: 03530744001 (L
  • Descripción del producto
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE;COBAS C 513 ANALYZER;COBAS 6000 - E601;COBAS INTEGRA SYSTEM - COBAS INTEGRA 800 ANALYZER;COBAS 8000 C502 STAND ALONE CONFIGURATION;URISYS 2400 ANALYSER;COBAS 8000 E602 IMMUNOASSAY ANALYZER;COBAS 8800;COBAS
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

ROCHE DIAGNOSTICS
  • Dirección del fabricante
    LAVAL
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    HC