Events

Retiro De Equipo (Recall) de VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty Diluent

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-00413-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-00413-1
  • 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 inc confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. internal testing determined that results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor.
  • Acción
    Ortho Clinical Diagnostics is requesting their customers to discontinue use and discard any remaining stock from the affected lots of diluent. Replacements from unaffected lots are available. This action has been closed-out on 11/04/2016

Device

VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS...
  • Modelo / Serial
    VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty DiluentProduct Code: 8559825Lot Number: F3168Expiry Date: 30 Sep 2014VITROS Chemistry Products FS Diluent Pack 3Product Code: 6801754Lot Number: 01-3266Expiry Date: 23 Sep 2014
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics