Events

Retiro De Equipo (Recall) de Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Beckman Coulter Australia 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-2014-RN-01350-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-23
  • 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-2014-RN-01350-1
  • 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
    N-acetyl cysteine (nac), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been recently determined to interfere with the detection of the following analytes on beckman coulter clinical chemistry platforms: enzymatic creatinine, cholesterol, uric acid, lactate, and lipase. nac is an anti-oxidant and can interfere with assays and this may lead to falsely low results and subsequent mistreatment.
  • Acción
    The instructions for use will be amended to contain a warning pertaining to patients being treated with N-Acetyl Cysteine (NAC) for a paracetamol overdose may generate false low results for specific tests. This action has been closed-out on 26/08/2016.

Device

Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase Assays
  • Modelo / Serial
    Enzymatic Creatinine, Cholesterol, Uric Acid, Lactate, and Lipase AssaysEnzymatic Creatinine Reference Number: OSR6X204Cholesterol Reference Number: OSR6X16Uric Acid Reference Number: OSR6X98Lactate Reference Number: OSR6X93Lipase Reference Number: OSR6X30All lot numbers affected ARTG Number: 200018In Vitro Diagnostic Medical Devices (IVDs)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd