Events

Retiro De Equipo (Recall) de VITROS Performance Verifier I for unconjugated bilirubin (Bu)

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-2015-RN-00465-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-05
  • 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-00465-1
  • 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
    Investigations have been performed by ortho clinical diagnostics to investigate and address an increase in customer complaints generated for low outside the range of means pv level i results on multiple vitros bu reagent lots and multiple vitros pv lots. review of the customer complaints indicate that some customers are observing results that are outside the range of means (rom), within 0.1 mg/dl of the low end.The differences observed in bu range of means capabilities are not clinically significant and the accuracy of the patient sample results is not impacted by this situation, however there is potential for results to be delayed.
  • Acción
    New Assay Sheets containing the revised Range of Means for Bu have been made available on the VITRIOS website. This action has been closed-out on 02/05/2017.

Device

VITROS Performance Verifier I for unconjugated bilirubin (Bu)
  • Modelo / Serial
    VITROS Performance Verifier I for unconjugated bilirubin (Bu)Product Code: 8067324 AUST L 25922Lot numbers: A3823, C4084, Q2961, T3161, V3297, X3569 An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics