Events

Retiro De Equipo (Recall) de COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)

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
    116772
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-03
  • 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
    Following a production change of connector types for the sample probe plug it was confirmed by the manufacturer that in very rare cases a disturbance of the sample liquid level detection (lld) may occur. this may cause the affected sample probe to dip into the sample material deeper than intended causing the affected sample probe to be washed inadequately and lead to a potential carryover.

Device

COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)
  • Modelo / Serial
    Model Catalog: 04826876001 (Lot serial: 16F9-20); Model Catalog: 04826876001 (Lot serial: 16F9-10 to 16F9-18); Model Catalog: 04826876001 (Lot serial: 15D0-01 to 16D8-20); Model Catalog: 04826876001 (Lot serial: 16D9-02 to 16E0-10); Model Catalog: 06473245001 (Lot serial: 15F6-07 to 17M8-10); Model Catalog: 04826876001 (Lot serial: 16E0-16 to 16F9-08); Model Catalog: 04745914001 (Lot serial: 15P1-01 to 16Y4-19); Model Catalog: 04745914001 (Lot serial: 16Y5-01 to 17Z3-20); Model Catalog: 05641489001 (Lot serial: 15E6-01 to 17H7-10); Model Catalog: 05964075001 (Lot serial: 17L9-10); Model Catalog: 05964067001 (Lot serial: 15A6-01 to 16D9-10); Model Catalog: 05964075001 (Lot serial: 15D5-01 to 17L8-10); Model Catalog: 05964075001 (Lot serial: 17L9-09)
  • Descripción del producto
    COBAS 4000 - COBAS C 311;COBAS 8000-C702 CHEMISTRY ANALYZER;COBAS 6000 - C501 CHEMISTRY ANALYZER;COBAS 8000-C701 CHEMISTRY ANALYZER;ISE1800 ADDITIONAL MODULE FOR COBAS 8000;559756 COBAS 8000-C502 CHEMISTRY ANALYZER
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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