Events

Retiro De Equipo (Recall) de MIA FORA NGS HLA FLEX 11 KIT (24 tests). 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 Diagnostic Solutions 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-2017-RN-01491-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-06
  • 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-2017-RN-01491-1
  • 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
    Diagnostic solutions has been made aware by the manufacturer, bioarray solution, that a limited number of mia fora ngs hla flex 11 kit (24 tests) ce kits lot 18- 107-11-c contain index adaptor plates (iap) p/n sr-800-00349, lot 18-30a that may result in incorrect calls for samples in the f1 and g1 plate positions due to switched barcode adaptors in positions f1 and g1. the impact of a defective iap when used for testing will result in the wrong call at plate positions f1 and g1 and therefore an incorrect result.
  • Acción
    Diagnostic Solutions is advising customers to quarantine all units of Lot 18-107-11-C from inventory. Diagnostic Solutions will confirm with users whether any of their stock is defective and will arrange for replacement of defective units. Diagnostic Solutions recommend that all F1 and G1 sample results generated with the MIA FORA NGS HLA FLEX 11 KIT (24 tests) Lot 18-107-11-C are retested to confirm samples have been correctly identified.

Device

MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    MIA FORA NGS HLA FLEX 11 KIT (24 tests). An in vitro diagnostic medical device (IVD) Lot Number: 18-107-11-CARTG Number: 288368
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd