Events

Rappel de WIZARD2 Gamma Counters. 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 PerkinElmer.

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-00250-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-04
  • 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-00250-1
  • 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
    This is a follow up to a previous recall in 2015 (tga ref: rc-2015-rn-00417-1). it has been identified that the affected barcodes were distributed from february 2010, not june 2012 as originally understood. perkinelmer have become aware that the content of the second of the two #023 barcode id labels provided on each page of the barcode id label binder are incorrect. the second barcode id label #023 symbol incorrectly identifies as #024 when scanned. in the event measurement protocols have been programmed for both id #023 and #024, and the wizard2 gamma counter scans the affected barcode label, the protocol associated with barcode id #024 is executed. if the error is undetected, the wizard2 gamma counter may produce erroneous results.The issue will lead to a delay in reporting results due to the delay to resolve the issue and retest the samples or test new samples. dependent on individual patient clinical status an incorrect result may impact disease progression or renal function.
  • Action
    Users are advised to ensure that they remove the barcode labels ID #023 from all barcode label binders in their possession. Please be sure to inspect all sample racks to remove and destroy any barcode ID labels #023 already affixed to racks. A WIZARD2 Gamma Counter barcode label binder with corrected barcode labels ID #023 will be provided to affected customers. This action has been closed-out on 18/05/2017.

Device

WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    WIZARD2 Gamma Counters. An in vitro diagnostic medical device (IVD)WIZARD2 1-detector, 550 samplesCatalogue Number: 2470-0010WIZARD2 2-detector, 550 Catalogue Number: 2470-0020WIZARD2 5-detector, 550 Catalogue Number: 2470-0050 WIZARD2 1-detector, 3",1000Catalogue Number: 2480-0010Multiple Serial Numbers affectedARTG Number: 209297
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer