Events

Rappel de VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)

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-2013-RN-00254-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-03-19
  • 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-00254-1
  • 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 has received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using vitros chemistry products phbr slides. an investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
  • Action
    End users are requested to discard all lots of VITROS PHBR Slides. It is recommended that any concerns with previously reported patient results be discussed with the laboratory director and requesting physician.

Device

VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quanti...
  • Modèle / numéro de série
    VITROS Chemistry Products PHBR Slides (An in vitro diagnostic medical device (IVD) for the quantitative measure of phenobarbital)GEN 38. Coating 0060GEN 39. Coating 0062GEN 40. Coating 0063GEN 41. Coating 0064Expiry date range: 1 April 2013 through 1 February 2014
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics