Events

Retiro De Equipo (Recall) de Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. 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 Agilent Technologies 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-01482-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-06
  • 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-01482-1
  • 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 certificate of analysis (coa) and the primary labels of the affected vials of m3636 were mislabelled with an incorrect protein concentration value of 292.7 mg/l, which is sixteen times higher than the correct concentration of 18.3 mg/l. to date, agilent has received only one customer complaint about this issue. the customer detected the issue prior to testing and immediately contacted agilent. no patient harm was reported, and the customer had informed that they were able to complete the patient’s diagnostic testing with minimal delay.M3636 will perform as expected. there is no change to the concentration itself, just the incorrect concentration stated on the vial label and the coa. the secondary label (box label) contains the correct concentration of 18.3 mg/l.
  • Acción
    Agilent Technologies Australia is advising customers to discard any affected vials of Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2, Code No. M3636 in accordance with the IFU. Agilent Technologies will arrange for replacement of product from affected customers. Agilent Technologies is advising users who may have run results at an altered dilution due to the larger protein concentration and without appropriate run controls to review results and re-run where required.

Device

Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2. An in vitro diagnostic medical device (IVD)Product number: M3636Material Number: M363629-2Lot Number:10121365 Material Number: M363601-2Lot Number:10117361ARTG Number: 269420
  • Manufacturer
    Agilent Technologies Australia Pty Ltd

Manufacturer

Agilent Technologies Australia Pty Ltd