Events

Rappel de VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). 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 Australia Pty Ltd.

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-01376-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-10-18
  • 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-01376-1
  • 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 confirmed that some barcode labels included in some vitros calibrator kit 25, lot 2576 cartons contain an incorrect lot number. the labels indicate lot 2575 instead of the correct lot 2576 for all three calibrator levels. the printed barcode labels are used with the automatic calibration feature when calibrating vitros 4600 or 5600 systems. when the operator attempts to use the affected barcode labels to calibrate vitros dhdl slides, a ‘pzc-006’ condition code occurs, indicating that the calibrator lot is not supported by the assay data disk (add); therefore the calibration is not successful. all labelling on the calibrator vials and the carton is correct. lot 2576 calibrators perform as expected if the operator manually programs the correct lot information for calibration.
  • Action
    Ortho is advising users to inspect the barcode labels provided in VITROS Calibrator Kit 25, Lot 2576, discard affected labels that indicate Lot 2575, and to manually program Lot 2576 when calibrating VITROS dHDL Slides.

Device

VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Che...
  • Modèle / numéro de série
    VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD).Product Code: 6801896Lot Number: 2576Expiry Date: 02 Sept 2017ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics Australia Pty Ltd

Manufacturer

Ortho-Clinical Diagnostics Australia Pty Ltd