Events

Retiro De Equipo (Recall) de VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs 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-2014-RN-00820-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-07-24
  • 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-00820-1
  • 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
    Ortho-clinical diagnostics (ocd) received complaints of results for patient and proficiency samples were elevated in some instances. proficiency sample results when using vitros ca 19-9 kit lot 1320, compared to previous kit lots used and analysed (ocd internal testing), found an overall average positive bias of approximately +30% for samples within the normal range (<=37 u/ml) and +17% for samples above the normal range (>37 u/ml).
  • Acción
    Laboratories are being advised to immediately discontinue using and discard all remaining inventory of VITROS CA19-9 Calibrators and Reagent Packs, Lot 1320. Review previously reported results using VITROS CA 19-9 Reagent Packs, Lot 1320 and discuss any concerns regarding previously reported results with your Laboratory Medical Director or the requesting physician to determine the appropriate course of action. Ortho-Clinical Diagnostics (OCD) will provide credits/replace stock of any product affected by this recall. This action has been closed-out on 12/08/2016.

Device

VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic med...
  • Modelo / Serial
    VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs An in vitro diagnostic medical device (IVD)VITROS Immunodiagnostic Products CA 19-9 CalibratorsProduct Code: 6800035VITROS Immunodiagnostic Products CA 19-9 Reagent PackProduct Code: 6800040Lot Number: 1320Expiry Date: 12 September 2014
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics