Events

Retiro De Equipo (Recall) de ENGEN AUTOMATED SAMPLE HANDLING SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ORTHO-CLINICAL 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
    50376
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-08
  • 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
    Under certain conditions when an engen laboratory automation system (engen system) is configured with a recapper module there is a potential for recapper caps for use with the recapper module to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. there is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the rack entry/exit or rack exit module. these situations may result in splashing of bio-hazardous fluid and sample cross-contamination may occur if there is an uncapped tube in the rack.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Modelo / Serial
    Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: JCT20Q3J)
  • Descripción del producto
    ENGEN LABORATORY AUTOMATION SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS