Events

Rappel de VITROS Immunodiagnostic Products CK-MB 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-2013-RN-00367-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-23
  • 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-00367-1
  • 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 revised the storage instructions for vitros immunodiagnostic products ck-mb calibrators. internal testing demonstrated that opened-reconstituted vitros ck-mb calibrators stored at -20degc generated invalid calibrations that were detected by positively biased quality control results.
  • Action
    OCD is updating the instructions for use to reflect that refrigerated storage at 2-8 degrees centigrade is acceptable. OCD is asking users to discontinue use of units stored at -20 degrees centigrade. This action has been closed-out on 11/02/2016.

Device

VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)Product Code: 1286293
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics