Retiro De Equipo (Recall) de Sekisui Diagnostics Acetaminophen Reagent. 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 Abbott Australasia Pty Ltd Diagnostic Division.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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 current instructions for use reports the interference from n-acetylcysteine (nac) evaluated on a commercially available analyser. using a significance criterion of > 10% variance from control, acceptable results were obtained to a level of 800 mg/l n-acetylcysteine (nac) in a 104 ìg/ml (688 ìmol/l) acetaminophen sample; this in vitro analysis was performed approximately two hours after the addition of nac to a serum pool.Based on testing performed by sekisui diagnostics on an architect csystems instrument, the concentration of nac at which acceptable acetaminophen results are obtained is 200 mg/l nac in values from a 109 ìg/ml acetaminophen sample, tested two hours after the addition of nac to a serum pool.The package insert is being updated accordingly based on these results.
  • Acción
    Laboratories are advised that treatment with N-acetylcysteine (NAC) could interfere with the assay to a greater extent than previously indicated resulting in negative bias. The Instructions for Use have been updated with this warning. Laboratories are advised to follow their protocols regarding the need for review of previously reported results. This action has been closed-out on 18/04/2017.


  • Modelo / Serial
    Sekisui Diagnostics Acetaminophen Reagent. An in vitro diagnostic medical device (IVD)List Number: 2K99-20Lot Number: 45797UQ04Expiration Date: 30-JUN-2015Lot Number: 46121UQ07Expiration Date: 30-SEP-2015Lot Number: 46561UQ08Expiration Date: 31-OCT-2015Lot Number: 46207UQ09Expiration Date: 30-NOV-2015Lot Number: 46953UQ12Expiration Date: 29-FEB-2016
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source