Events

Retiro De Equipo (Recall) de ORTHO BioVue System Cassettes (blood typing and compatibility tests). 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-00721-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-08-06
  • 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-2013-RN-00721-1
  • 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 has identified isolated occurrences of improperly positioned cassette labels resulting in the barcode, lot number, expiration date and sequence number placed on the incorrect side of the cassette. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection.This issue potentially affects abd confirmation cassettes, rh/k cassettes, rh-hr cassettes, abo-dd grouping cassettes, abo-rh grouping cassettes and anti-human globulin neutral solution (poly/neutral cassettes).
  • Acción
    Ortho-Clinical Diagnostics (OCD) is requesting customers to discard any potentially affected lots. OCD is recommending discussion of previously reported patient results with the Laboratory Medical Director to determine the appropriate course of action. OCD can provide detailed information regarding the impact to previously reported results for each type of cassette. Please contact OCD for further information.

Device

ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medi...
  • Modelo / Serial
    ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medical device (IVD).Multiple products affectedARTG Number: 31036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics