Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

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
    44063
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-03-11
  • 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 inc. (ocd) is informing users of a software anomaly regarding microslide reagent management on the vitros 51 fs chemistry system (software version 2.8 & below). ocd has confirmed two instances where a vitros microslide cartridge was misidentified. both instances occurred when an operator accessed slide supply 1 (ss1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into slide supply 2. in each occurrence the loaded cartridge in slide supply 2 was misidentified. if this anomaly occurs it is possible for vitros 51 fs systems to process samples with a cartridge other than the intended cartridge potentially leading to erroneous patient results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Modelo / Serial
    Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    VITROS 51 FS CHEMISTRY SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS