Events

Rappel de Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD).

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Ortho-Clinical Diagnostics.

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-2015-RN-00033-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-14
  • 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-2015-RN-00033-1
  • 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
    Ortho clinical diagnostics (ocd) has received a report that when using a hand-held barcode scanner in combination with use of the batch programming option for programming samples, the scanner unexpectedly skips sample cup positions. for example, a sample tube barcode is scanned for the cup 1 position, the cursor in the batch programming screen skips the cup 2 position and advances to the cup 3 position. if this anomaly occurs, there is a potential for mis-associated results.
  • Action
    OCD is providing instructions on the reprogramming of the barcode scanner. Once the barcode scanner is reprogrammed the issue will not occur. This action has been closed-out on 15/07/2016

Device

Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic med...
  • Modèle / numéro de série
    Hand-held Barcode Scanner used with VITROS clinical chemistry systems. An in vitro diagnostic medical device (IVD).Product Code: 6844210ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics