Events

Retiro De Equipo (Recall) de iChem Velocity Urine Chemistry Strips. 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 Beckman Coulter 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-2015-RN-00806-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-04
  • 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-2015-RN-00806-1
  • 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 manufacturer, iris international has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. the manufacturer'sinvestigation was initiated based on customer complaints for control failures. iris international has become aware of a manufacturing defect where a glucose pad was placed in the location intended for the protein pad on a subset of vials numbered 14996 through 15859 (with the exception of vials 15315 and 15316 within that series) within lot number 7204081a.The manufacturing defect will cause:· consistent false negative results in the presence of proteinuria.· false positive urine protein results may occur when patient specimen contains glucose.· quality control failures for protein results.
  • Acción
    Beckman Coulter is advising users to inspect and discard any remaining inventory of affected vials. Beckman Coulter recommends consulting with the Laboratory Director to determine if a review of previously reported results is required. This action has been closed-out on 18/08/2016.

Device

iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)Lot Number: 7204081AExpiry Date: 02/2016Vials numbered 14996 through 15859 (except 15315 and 15316)ARTG Number: 177551
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd