Events

Rappel de VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS 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-2015-RN-00974-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • 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-2015-RN-00974-1
  • 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
    There is a potential for an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9, lot 0954.The increase in u90-382 and 6lu condition codes primarily occurs when using vitros dgxn and phyt slides. vitros acet and crbm slides are not affected. when the u90-382 or 6lu condition code occurs, the vitros system suppresses the result and no result is reported. all numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.
  • Action
    OCD is advising users to discontinue use and discard all remaining inventory of the affect lot. OCD will replace the affected units or provide a suitable credit. The affected lot may still be used until replacement lots are available. This action has been closed-out on 06/09/2016.

Device

VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS System...
  • Modèle / numéro de série
    VITROS Chemistry Products Calibrator Kit 9 (used on VITROS 250, 350, 4600, 5600 and 5,1 FS Systems). An in vitro diagnostic medical device (IVD).Product code: 8568040Lot Number: 0954Expiry Date: 31 May 2016Unique Device Identifier Number: 10758750005031ARTG number: 245278
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics