Events

Rappel de VITROS Chemistry Products HPT Reagent. 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.

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-2012-RN-01143-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-13
  • 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-2012-RN-01143-1
  • 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
    Customers have reported the inability to calibrate vitros hpt reagent due to an increase in "u91-274" condition codes. in cases of successful calibration, some customers have also reported an increase in "u91-274" condition codes that prevented results when processing patient samples and quality control fluids. a potential for biased results exists if the user is able to obtain a valid calibration and quality control (qc) may not detect the issue.
  • Action
    Discontinue and discard remaining inventory of VITROS HPT Reagent. Ortho-Clinical Diagnostics recommends discussing previously reported results with the Laboratory Director to determine the appropriate course of action.

Device

VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS Chemistry Products HPT Reagent. An in vitro diagnostic medical device (IVD)Product code: 6802214Lot number: 1533-19-2133 (Assay identifier 1533, GEN 19, Lot 2133); Expiration date: 20 Nov 2012Lot Number: 1533-20-2314 (Assay identifier 1533, GEN 20, Lot 2314); Expiration date: 11 Feb 2012
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics