Events

Retiro De Equipo (Recall) de CIDEX OPA Solution Test Strips

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-00298-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-04-01
  • 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-00298-1
  • 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 has determined that shelf life data for the cidex opa solution test strips is effective for only 10 months of the test strip’s labeled 12-month shelf life. there is no potential risk to patient safety, as test strips used at the end of shelf life would indicate a false negative (e.G. “fail” result for solution above the minimum effective concentration). this issue could be observed during either qc testing of the test strips prior to use (in accordance with the instructions for use) or during testing of cidex opa solution when the test strips are near the end of shelf life. there was no evidence that a false positive (e.G. a “pass” result for solutions below the mec) would occur.A corrective action is in place to update the shelf life of the cidex® opa solution test strips from 12 months to 10 months.
  • Acción
    Customers are requested to update the expiry date from 12 to 10 months. This action has been closed-out on 03/03/2016.

Device

CIDEX OPA Solution Test Strips

Manufacturer

Johnson & Johnson Medical Pty Ltd