Events

Rappel de VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. 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-2016-RN-00648-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-16
  • 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-2016-RN-00648-1
  • 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
    The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using vitros afp reagent packs.Ortho clinical diagnostics (ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. the investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. there have been no reports of injuries as a result of this issue.
  • Action
    Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives. Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017.

Device

VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medica...
  • Modèle / numéro de série
    VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)VITROS AFP Reagent PackDevice Identifier: 10758750006489Product Code: 1925551VITROS AFP CalibratorsDevice Identifier: 10758750006540Product Code: 1515154Lot Number: 1470Expiry Date: 13 Dec 2016ARTG Number: 248385
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics