Events

Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. 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-00648-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-16
  • 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-00648-1
  • 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
    The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using vitros afp reagent packs.Ortho clinical diagnostics (ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. the investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. there have been no reports of injuries as a result of this issue.
  • Acción
    Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives. Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017.

Device

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medica...
  • Modelo / Serial
    VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)VITROS AFP Reagent PackDevice Identifier: 10758750006489Product Code: 1925551VITROS AFP CalibratorsDevice Identifier: 10758750006540Product Code: 1515154Lot Number: 1470Expiry Date: 13 Dec 2016ARTG Number: 248385
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics