Events

Retiro De Equipo (Recall) de VITROS Performance Verifier II. 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 Australia Pty Ltd.

¿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-2017-RN-01008-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-10
  • 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-2017-RN-01008-1
  • 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 (ortho) determined that the unopened storage condition for vitros performance verifier ii, lot k4852 requires revision when using vitros chemistry products ast slides or vitros chemistry products astj slides.The instructions for use (ifu) states that unopened vitros performance verifier ii can be stored either frozen until the expiration date or refrigerated for =6 months. stability testing determined that unopened vials for lot k4852 did not meet the product’s 6 month specification when stored refrigerated. all other lots are not affected.Product that is stored frozen is not affected by this issue. customers can continue to use frozen-stored product through its expiration date.
  • Acción
    Ortho Clinical Diagnostics is requesting customers: 1. Be aware that unopened vials of Lot K4852 can no longer be stored refrigerated to verify the performance of VITROS AST or ASTJ Slides; 2. Discard any remaining inventory stored refrigerated if used to verify VITROS AST or ASTJ Slides; and 2. Retain this notification as verification of the revised instructions. Complete the Confirmation of Receipt form supplied with the customer letter and return by August 15th, 2017.

Device

VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)Product Code (Unique Identifier): 8231474 (10758750004577)Lot Number: K4852Expiry: 22 Feb 2018
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd