Events

Retiro De Equipo (Recall) de Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. 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 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-2015-RN-01017-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-10-19
  • 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-2015-RN-01017-1
  • 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
    Beckman coulter has confirmed that n-acetyl cysteine (nac) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the trinder chemical pathways; enzymatic creatinine (cr-e) and uric acid (uric). nac interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with nac.
  • Acción
    Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016.

Device

Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnosti...
  • Modelo / Serial
    Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnostic medical device (IVD)Product Codes: A60298 (CR-E), All Lot Numbers are affectedARTG Numbers: 213984 and 222819
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd