Events

Rappel de ThinPrep 5000 Processor with Autoloader

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hologic Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00516-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-26
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00516-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    ThinPrep 5000 Processor with AutoloaderARTG Number: 224862
  • Manufacturer
    Hologic Australia Pty Ltd

Manufacturer

Hologic Australia Pty Ltd