Events

Retiro De Equipo (Recall) de VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia 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
    RC-2016-RN-00420-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00420-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    A vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results.Scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample.Scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a.There is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury.
  • Acción
    Ortho is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. It is recommended to discuss any concerns regarding previously reported results with the Laboratory Medical Director to determine the appropriate course of action. Ortho will be providing users with a software update (software version 3.2.3) as a permanent correction. This can be automatically downloaded for systems connected to e-Connect or software kits provided for systems not connected to e-Connect. This action has been closed-out on 20/02/2017.

Device

VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 an...
  • Modelo / Serial
    VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below. An in vitro diagnostic medical device (IVD)VITROS 3600 Immunodiagnostics System, software version 3.2.2 and belowProduct Code: 6802783Unique Device ID: 10758750002979VITROS 5600 Integrated System, software version 3.2.2 and belowProduct Code: 6802413Unique Device ID: 10758750002740ARTG Number: 180199
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics