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
    121013
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-04-07
  • 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
    Ortho clinical diagnostics (ocd) internal testing has confirmed instances where vitros 51 fs 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen regardless of the pretreatment requirements for each selected assay potentially leading to biased patient results. urine samples for use with vitros ca mg and phos slides require acidification (pretreatment). the engen system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. in addition the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. depending upon the assay urine samples need to be acidified alkalized extracted or not treated prior to being processed on vitros systems.

Device

ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Modelo / Serial
    Model Catalog: ENGEN (Lot serial: J953234); Model Catalog: ENGEN (Lot serial: J41BCY4J); Model Catalog: ENGEN (Lot serial: J16XQH4J); Model Catalog: ENGEN (Lot serial: J1HX7S4J); Model Catalog: ENGEN (Lot serial: J953244); Model Catalog: ENGEN (Lot serial: JCT20Q3J)
  • Descripción del producto
    ENGEN LABORATORY AUTOMATION SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS