Retiro De Equipo (Recall) de Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Taylor Bio-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-2016-RN-01270-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-23
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    A typographical error has been identified in certain quantum blue calprotectin assay kits. the printed expiration date on the labelling of the kits is incorrect. the correct expiry date is 2016-dec-31. there is no risk to health if the assay kits are used by this date.
  • Acción
    Taylor Biomedical has advised customers to check if they have affected stock. Customers will be requested to include in the affected stock, an advisory notice with details of the correct expiry date. This action has been closed-out on 28/11/2016.

Device

  • Modelo / Serial
    Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High RangeQuantum Blue Calprotectin AssayLot Numbers: 2930N Expiry: 2017-July-31Quantum Blue Calprotectin High RangeLot Number: 2930N.HR Expiry: 2017-April-30
  • Manufacturer

Manufacturer