Events

Rappel de ORTHO BioVue System Cassettes (blood typing and compatibility tests). 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-2013-RN-00721-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-06
  • 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-00721-1
  • 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 identified isolated occurrences of improperly positioned cassette labels resulting in the barcode, lot number, expiration date and sequence number placed on the incorrect side of the cassette. the use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection.This issue potentially affects abd confirmation cassettes, rh/k cassettes, rh-hr cassettes, abo-dd grouping cassettes, abo-rh grouping cassettes and anti-human globulin neutral solution (poly/neutral cassettes).
  • Action
    Ortho-Clinical Diagnostics (OCD) is requesting customers to discard any potentially affected lots. OCD is recommending discussion of previously reported patient results with the Laboratory Medical Director to determine the appropriate course of action. OCD can provide detailed information regarding the impact to previously reported results for each type of cassette. Please contact OCD for further information.

Device

ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medi...
  • Modèle / numéro de série
    ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medical device (IVD).Multiple products affectedARTG Number: 31036
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics