Events

Rappel de G-6-PDH Control Kits, Normal. 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 Immuno 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-2013-RN-00369-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-29
  • 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-2013-RN-00369-1
  • 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
    Following an investigation of customer complaints, the affected lot numbers have been found to have poor stability following reconstitution. it has been confirmed that the reconstituted control does not maintain the full 7 day stability when stored at 2-8degc as stated in the package insert. the control may recover within range on day 1 after reconstitution, but will fall out of range before reaching 7 days.This recall action was carried out prior to approval of the recall strategy by the tga.
  • Action
    Immuno is advising users to discontinue use of the affected lots, and destroy remaining stock. Affected stock will be replaced by Immuno.

Device

G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    G-6-PDH Control Kits, Normal. An in vitro diagnostic medical device (IVD)Product Code: G6888Lot Numbers: 035, 036, 037 & 038Expiration Date: 2013-12
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA