Retiro De Equipo (Recall) de Injection Pipette

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por The Pipette Company 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-2018-RN-00170-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-26
  • 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
    The pipette company (tpc) has been made aware of a potential dimensional issue with the injection pipettes which may result in a narrow internal diameter (id) of the pipette tip. a narrow internal diameter, below the acceptance criteria, may cause technical difficulties, including aspiration of sperm as sperm cannot be loaded into an overly narrow injection pipettes.
  • Acción
    The Pipette Company is advising affected customers to complete the reply form supplied with the Customer Letter to schedule refund or exchange.

Device

  • Modelo / Serial
    Injection PipettePart Number: LICR-0D5Multiple Affected Lot NumbersManufacturing dates: May 2017-October 2017ARTG Number: 160455(The Pipette Company Pty Ltd - Micropipette, user-induced)
  • Manufacturer

Manufacturer