Events

Rappel de VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) 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-01318-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-19
  • 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-2016-RN-01318-1
  • 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
    It has been identified that results obtained from vitros intact parathyroid hormone (ipth) reagent packs are positively biased (i.E. falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs. this bias is consistent for all in-date lots. due to this positive bias, samples from patients with normal levels of ipth may be above the current reference interval. therefore, the reference interval as defined in the instructions for use (7. 5-53.5 pg/ml (0.8-5.7 pmol/l)) is no longer supported. the lot in which the bias originated has not been identified, so this issue affects all in-date lots and potentially lots that have expired.Due to limited availability of samples with ipth concentrations >100 pg/ml, ortho's root cause investigation of the issue is ongoing.
  • Action
    Ortho is advising users to immediately stop performing the VITROS Intact PTH test using VITROS Intact iPTH Reagent Packs and Calibrators, and discard Reagent Packs and Calibrators from the affected lot numbers. Ortho will issue credit for discarded lots. For results previously generated using the known affected lots, any concerns should be discussed with the Laboratory Director. For results obtained with other lots that have expired, a review of previous results may be impractical as the lot in which the bias originated has not been identified. This action has been closed-out on 28/02/2018.

Device

VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ...
  • Modèle / numéro de série
    VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD)Intact PTH Reagent PackProduct Code: 6802892Lot Numbers: 0700 (exp.18-10-16), 0710 (exp. 14-11-16), 0748 (exp. 6-2-17), 0758 (exp. 6-3-17)Intact PTH CalibratorsProduct Code: 6802893Lot Numbers: 0728 (exp.12-12-16), 0738 (exp. 2-1-17), 0768 (exp.10-4-17)ARTG number: 176641
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics