Events

Retiro De Equipo (Recall) de VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS MicroSlide Calibrator Kit Numbers: 1 - 10 (inc.) & 25

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-2014-RN-01001-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-09-17
  • 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-2014-RN-01001-1
  • 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
    An unexpected assay calibration may occur when using calibrator barcode labels supplied with vitros chemistry products calibrator kits for assay targets that are unassigned.
  • Acción
    A correction for this issue will be included in the next version of the software. Ortho-Clinical Diagnostics is requesting their customers to not use the calibrator barcode labels for VITROS Calibrator Kits 1, 2, 3, 4, 6, or 9 until the next version of software is installed on the VITROS System. This action has been closed-out on 25/08/2016.

Device

VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS M...
  • Modelo / Serial
    VITROS 4600 Chemistry Systems & VITROS 5600 Integrated Systems Using Software Version 3.0VITROS MicroSlide Calibrator Kit Numbers: 1 - 10 (inc.) & 25ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics