Events

Retiro De Equipo (Recall) de ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). 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-00758-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-10
  • 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-00758-1
  • 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
    Previously unknown drug interferences from sulfasalazine and sulfapyridine have been identified. there is a possibility that drug interference's from administration of sulfasalazine to patients may generate false low alt results and false low glucose-stat results. sulfapyridine may generate false high glucose-stat results (osr6x40).Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 35% for the low alt control and up to 29% for the high alt control.Interference seen with 300mg/l sulfasalazine showed a negative bias of up to 25% (or 1.3 mmol/l) for the low glucose-stat control and up to 13% (or 1.6mmol/l) for the high glucose-stat control.Interference seen with 300mg/l sulfapyridine showed a positive bias of up to 21% (or 1.1 mmol/l )for the low glucose-stat control and up to 9% or (1.1mmol/l) for the high glucose-stat control.There is no risk to patients however there is the potential for a delay in results.
  • Acción
    Beckman Coulter is advising users that the IFU has been updated to include additional warnings in the 'Interfering Substances' section. No retrospective review of results is recommended.

Device

ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnost...
  • Modelo / Serial
    ALT and Glucose-Stat Assays (used for the determination of ALT and Glucose). An in vitro diagnostic medical device (IVD)Reference numbers: ALT OSR6X07, Glucose-Stat OSR6X40All lots affectedARTG numbers: 200015, 200018
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd