Events

Rappel de Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen

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

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-00401-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-05-13
  • 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-00401-1
  • 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
    Siemens healthcare diagnostics has confirmed that the immulite 2000/immulite 2000 xpi italian cypress allergen lot 206 does not meet the shelf-life stability as indicated on the label. this may lead to single class change decrease (standard classification) in patient results across the current shelf-life of this allergen lot. patient dose values may decrease before the stated expiry date listed on the allergen vial.It is expected that lot 208 will also not meet its current shelf life stability and must be discarded after june 30, 2015.
  • Action
    Siemens is requesting laboratories to discard IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen from lot 206. The shelf-life of IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress allergen, lot 208, has been shortened to June 30, 2015. Laboratories are requested to discontinue use and discard lot 208 after June 30, 2015.

Device

Immulite 2000 and Immulite 2000 XPi – Italian Cypress Allergen
  • Modèle / numéro de série
    Immulite 2000 and Immulite 2000 XPi – Italian Cypress AllergenSiemens Material Number: 10386079Lot Numbers: 206 and 208ARTG number: 198420
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA