Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    52233
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-06-10
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Ocd has announced a recall to inform customers of a change to the frequency of replacement for the cm/rt wear pads on vitros 5600 4600 and 51 fs systems. cm/rt wear pads are a component in the cm/rt incubator. the cm/rt rotor revolves on three wear pads within the incubator. by design there is a small gap between the rotor and the hot plate to allow for the transfer of heat. if the wear pads become too thin it may cause the rotor to rub on the hot plate resulting in black dust within the incubator. the impact of black dust may contribute to unplanned system down time. we have no data that suggests that black dust has any adverse effect on results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Modèle / numéro de série
    Model Catalog: 6801375 (Lot serial: > 10 contact manufacturer); Model Catalog: 6802413 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801890 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    VITROS 51 FS Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS