Events

Retiro De Equipo (Recall) de ThinPrep 5000 Processor with Autoloader

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hologic 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-00516-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-26
  • 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-00516-1
  • 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
    An investigation of customer complaints has determined that in rare cases, it is possible for the thinprep 5000 processor with autoloader to misread the value encoded in the vial barcode label. this occurs when the barcode scanner decodes a value that meets all symbology rules and check-digit validation but is not the intended value encoded in the barcode and processes the vial using this identifier. this potential is only present in thinprep 5000 processor with autoloader configurations and is not present in the benchtop configuration. in an autoloader configuration, if a misread occurs, the misread vial id value is transferred to the slide and a slide is produced with the incorrect identifier. there is a risk of misidentification of a patient slide.
  • Acción
    Hologic is advising users to ensure the labels are graded against the appropriate standard. The Technical Information Reference Guide has been updates to clarify the barcode quality and specification requirements. Hologic is providing users with a software update to perform additional safety reads to improve identification of inadequate labels. Hologic is also providing users with updated barcode scanners. This action has been closed out on 19/01/2016.

Device

ThinPrep 5000 Processor with Autoloader

Manufacturer

Hologic Australia Pty Ltd