Events

Rappel de VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty Diluent

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.

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-2014-RN-00413-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-07
  • 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-2014-RN-00413-1
  • 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 inc confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. internal testing determined that results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor.
  • Action
    Ortho Clinical Diagnostics is requesting their customers to discontinue use and discard any remaining stock from the affected lots of diluent. Replacements from unaffected lots are available. This action has been closed-out on 11/04/2016

Device

VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS...
  • Modèle / numéro de série
    VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3VITROS Chemistry Products Specialty DiluentProduct Code: 8559825Lot Number: F3168Expiry Date: 30 Sep 2014VITROS Chemistry Products FS Diluent Pack 3Product Code: 6801754Lot Number: 01-3266Expiry Date: 23 Sep 2014
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics