Events

Rappel de VITROS Performance Verifier II. 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 Ortho-Clinical Diagnostics 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-2017-RN-01008-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • 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-2017-RN-01008-1
  • 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
    Ortho clinical diagnostics (ortho) determined that the unopened storage condition for vitros performance verifier ii, lot k4852 requires revision when using vitros chemistry products ast slides or vitros chemistry products astj slides.The instructions for use (ifu) states that unopened vitros performance verifier ii can be stored either frozen until the expiration date or refrigerated for =6 months. stability testing determined that unopened vials for lot k4852 did not meet the product’s 6 month specification when stored refrigerated. all other lots are not affected.Product that is stored frozen is not affected by this issue. customers can continue to use frozen-stored product through its expiration date.
  • Action
    Ortho Clinical Diagnostics is requesting customers: 1. Be aware that unopened vials of Lot K4852 can no longer be stored refrigerated to verify the performance of VITROS AST or ASTJ Slides; 2. Discard any remaining inventory stored refrigerated if used to verify VITROS AST or ASTJ Slides; and 2. Retain this notification as verification of the revised instructions. Complete the Confirmation of Receipt form supplied with the customer letter and return by August 15th, 2017.

Device

VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)Product Code (Unique Identifier): 8231474 (10758750004577)Lot Number: K4852Expiry: 22 Feb 2018
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd