Events

Rappel de Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. 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-01257-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-28
  • 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-01257-1
  • 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, inc. (ocd) has determined that the default dilution factors on the calibration diskette (cal disk) and assay data disks (add), drv 5740 and below, are incorrect. it has also been determined that the 2nd dilution factors contained in the engen laboratory automation system configuration (.Gsb) file (version 3.2.2 & below) are incorrect.
  • Action
    Ortho-Clincial Diagnostics is providing their customers with Local Cal Disk or ADD version 5741 which contains the correct dilution factors. Customers are also advised to review their LIS data to determine the impact of the revised default dilution factors. For those customers using the enGen system, an Ortho-Clinical Diagnostics representative will assist in the development of revised dilution factors. This action has been closed-out on 12/02/2016.

Device

Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro dia...
  • Modèle / numéro de série
    Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD)VITROS Chemistry Instruments: -VITROS 4600-VITROS 5600-VITROS 250-VITROS 350-VITROS 5,1 FS-enGen systemVITROS Chemistry Products:ALT slides -1655281 CK slides -8479396, -8478034LDH slides -8384489 hsCRP reagent -6801739 THC reagent -6801994 TIBC kit -8867541 METD reagent -6801996 CRBM slides -8892382
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics