Events

Retiro De Equipo (Recall) de Alere Cholestech LDX ALT-AST Cassette (An in vitro medical device (IVD) used for the quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in whole blood)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Inverness Medical Innovations Australia Pty Ltd T/A Alere.

¿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-2013-RN-00225-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-14
  • 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-2013-RN-00225-1
  • 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 product may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for alt or ast compared to a reference method or repeat testing on the same patient sample. such differences may not be detected by the quality control testing.
  • Acción
    Inverness Medical Innovations (trading as Alere) is asking customers to discontinue the use of the affected lots and destroy all remaining stock. If questions arise regarding any previously reported ALT or AST results, Alere is recommending customers to consult the resident clinical expert or physician in the setting where the test was performed. The manufacturing of the Alere Cholestech LDX ALT.AST cassette has been suspended indefinitely and no current estimate for when the product may return to the market

Device

Alere Cholestech LDX ALT-AST Cassette (An in vitro medical device (IVD) used for the quantitative...
  • Modelo / Serial
    Alere Cholestech LDX ALT-AST Cassette (An in vitro medical device (IVD) used for the quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in whole blood)Catalogue Number: CT12-788Lot Number: 297313AARTG Number: 160951
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • 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
    DHTGA