Events

Rappel de Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Abacus ALS 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-2018-RN-00023-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-09
  • 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-2018-RN-00023-1
  • 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 issue has been found with the stability of immunocap allergen c5, ampicilloyl and immunocap allergen c6, amoxicilloyl. an internal monitoring real time stability study determined that the stability specifications were not met. the products have a nominal 12 months shelf life stated on the label.The reduced stability may result in erroneous test results for affected lot numbers.No other immunocap tests are affected by this issue. no adverse events have been reported to date.
  • Action
    Abacus is advising customers to discard any unused product. New product is expected to be available in Q3 2018. A review of previous results reported below the assay Limit of Quantification is advised.

Device

Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medi...
  • Modèle / numéro de série
    Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, AmoxicilloylAn in vitro medical deviceMaterial Numbers: 14-4450-01 and 14-4451-01Multiple Affected Lot NumbersARTG: 186054
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd