Events

Rappel de COULTER ReticPrep Reagent Kit (used for reticulocyte counting). 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 Beckman Coulter 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-00151-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-02-08
  • 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-00151-1
  • 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
    Beckman coulter has received an increased number of customer complaints related to the inability to scan or manually enter the reticprep barcode label. the reticprep barcode label number 2 contains characters that are not recognised by the software ("+$$" instead of "22"), and due to this issue the system will not generate results.The reported issue may lead to a delay in test results reporting. however, it is unlikely to cause adverse health consequences.
  • Action
    Beckman Coulter is advising users to follow the IFU to manually enter barcode number 2 with "22" in place of "+$$" which is printed on the label.

Device

COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical de...
  • Modèle / numéro de série
    COULTER ReticPrep Reagent Kit (used for reticulocyte counting). An in vitro diagnostic medical device (IVD)Reference Number: 7546978 Lot Number: 108912K Expiry Date: 11/12/2016ARTG Number: 223049
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd