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
    22543
  • 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 inc. (ocd) has confirmed instances where the vitros system allowed urine samples for assays that required acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. this has been attributed to a software anomaly. depending upon the assay urine samples either need to be acidified alkalized or require no pretreatment. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contains assays requiring sample pretreatment and assays requiring no sample pretreatment. if this anomaly occurs it is possible for vitros 51 4600 or 5600 systems to process urine samples without the proper pretreatment potentially leading to biased patient results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Modelo / Serial
    Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802413 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802445 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    VITROS 51 FS CHEMISTRY (DEVICE LICENCE #66236)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS