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
    56769
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-01-16
  • 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
    There is a potential sample mismatch that could occur between samples processed on the same rack on the cobas 6500 u601 urine analyzer and/or cobas u701 microscopy analyzer. the issue can occur if the sensors are misadjusted (either after transportation of the instrument or service has been performed on the sensor itself). there is no indication that the sensors can become misadjusted during operation. the analyzer may not transport the rack correctly so that tubes might be detected twice. as a consequence the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack identification (id). hence a sample mismatch is possible between samples processed on the same rack because the tubes are pipetted in the order given by the rack position and the test result is assigned to the wrong sample id.

Device

COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
  • Modelo / Serial
    Model Catalog: 06390498001 (Lot serial: ALL); Model Catalog: 06390501001 (Lot serial: All)
  • Descripción del producto
    COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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