Events

Retiro De Equipo (Recall) de Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. 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-2016-RN-00577-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-11
  • 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-2016-RN-00577-1
  • 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
    There is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results. metamizole (dipyrone) has been identified as an interferent which may cause false low results in certain assays. this is a previously undocumented interferent.These interferences are based on a chemical interaction with the trinder reaction, similar to nac interference previously identified by beckman coulter and may result in an error in diagnosis or patient management.No customer complaints have been received for this particular issue.
  • Acción
    Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences. A review of previously generated patients results is at the discretion of the Laboratory Director.

Device

Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. A...
  • Modelo / Serial
    Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD)Product Codes: OSR6X204, OSR6X16, OSR6X118, OSR6X98, OSR6X93, OSR6X30All lot numbers affectedARTG Numbers: 200018, 200015
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd