Events

Rappel de VITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibrators (used with ECi/ECiQ, 3600 Immunodiagnostic Systems and 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-00209-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-29
  • 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-00209-1
  • 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 (ortho) got reports that their vitros system reported results up to approximately 7.40 miu/ml (iu/l) for patient plasma samples that should have been less than the measuring range of the assay (<2.39 miu/ml (iu/l)). ortho’s investigation identified that results generated using plasma samples were positively biased compared to those using serum samples for the same patient. data indicates that samples expected to be less than the measuring range (<2.39 miu/ml (iu/l)) may potentially be reported as high as 7.72 miu/ml (iu/l). a low false positive hcg result, indicating a suspected very early pregnancy, may cause a delay of a therapeutic procedure or a diagnostic imaging procedure involving radiation, which may potentially lead to the delay of diagnosis and patient management.
  • Action
    Ortho is advising users to discontinue use and discard all remaining inventory of the affected reagent packs and calibrators. Affected stock will be replaced with unaffected product. Ortho is recommending a review of previously reported hCG results of <9.00mIU/mL(IU/L) for plasma samples processed using the affected lots and discuss any concerns with the Laboratory Medical Director.

Device

VITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibrators (used with ECi/ECiQ, ...
  • Modèle / numéro de série
    VITROS Immunodiagnostic Products Total B-hCG II Reagent Packs & Calibrators (used with ECi/ECiQ, 3600 Immunodiagnostic Systems and 5600 Integrated Systems). An in vitro diagnostic medical device (IVD)VITROS Total B-hCG II Reagent PacksUnique Device ID: 10758750002320, 20758750002327Product Code: 6802220VITROS Total B-hCG II CalibratorsUnique Device ID: 10758750002337, 20758750002334Product Code: 6802221Lot Number: 1420Expiry date: 17/06/2016ARTG Number: 176641
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics