Events

Retiro De Equipo (Recall) de VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). 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-2013-RN-01099-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-25
  • 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-2013-RN-01099-1
  • 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) has conformed that positively biased serum or plasma sample results may occur by up to +1.5mmol/l.
  • Acción
    OCD will replace your remaining inventory for VITROS® Na+ Slides calibrated with Lots 212 and 292. It is acceptable to use Lot 212 or 292 to calibrate VITROS® CHOL, Cl-, ECO2, and TRIG Slides until your replacement product arrives. This action has been closed-out on 01/02/2016.

Device

VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 C...
  • Modelo / Serial
    VITROS Chemistry Products Na+ Slides and Calibrator Kit 2 (used on VITROS 250/350/5, 1 FS, 4600 Chemistry Systems, VITROS 5600 Integrated System). An in vitro diagnostic medical device (IVD)VITROS Chemistry Products Na+ SlidesProduct Code: 8379034Lot Numbers: GENs 7 to 13Expiry Dates: 01/11/2013 to 01/01/2015VITROS Chemistry Products Calibrator Kit 2Product Code: 1662659Lot Numbers: 212, 292Expiry Dates: 31/08/2014, 28/02/2014
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics