Events

Retiro De Equipo (Recall) de VITROS Chemistry Products HPT Reagent. 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-2012-RN-01143-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-13
  • 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-2012-RN-01143-1
  • 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
    Customers have reported the inability to calibrate vitros hpt reagent due to an increase in "u91-274" condition codes. in cases of successful calibration, some customers have also reported an increase in "u91-274" condition codes that prevented results when processing patient samples and quality control fluids. a potential for biased results exists if the user is able to obtain a valid calibration and quality control (qc) may not detect the issue.
  • Acción
    Discontinue and discard remaining inventory of VITROS HPT Reagent. Ortho-Clinical Diagnostics recommends discussing previously reported results with the Laboratory Director to determine the appropriate course of action.

Device

VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)Product code: 6802214Lot number: 1533-19-2133 (Assay identifier 1533, GEN 19, Lot 2133); Expiration date: 20 Nov 2012Lot Number: 1533-20-2314 (Assay identifier 1533, GEN 20, Lot 2314); Expiration date: 11 Feb 2012
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics