Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2

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
    74006
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-06-05
  • 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 issued a recall pertaining to a potential malfunction in a wire connector used in the vitros 4600 vitros 5600 and vitros 51 fs systems that were shipped during a specific date range. to date six customers reported the smell of melting plastic or observed smoke originating from their vitros 4600 and 5600 systems. although reports are confined to the vitros 4600 and 5600 systems the same wire connector is also used on vitros 51 fs systems. as a precaution ocd is contacting customers to notify them of this potential malfunction for vitros systems that were shipped during a specific date range.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYS. - REFURBISHED ANAL. CLASS 2
  • Modèle / numéro de série
    Model Catalog: 6801890 (Lot serial: 34001610); Model Catalog: 6801890 (Lot serial: 34001589); Model Catalog: 680 2445 (Lot serial: 46000159); Model Catalog: 680 2445 (Lot serial: 46000140); Model Catalog: 680 2445 (Lot serial: 46000160); Model Catalog: 680 2445 (Lot serial: 46000142); Model Catalog: 680 2445 (Lot serial: 46000115); Model Catalog: 6802413 (Lot serial: 56001220); Model Catalog: 6802413 (Lot serial: 56001229); Model Catalog: 6802413 (Lot serial: 56001205); Model Catalog: 6802413 (Lot serial: 56001234); Model Catalog: 6802413 (Lot serial: 56001231); Model Catalog: 6802413 (Lot serial: 56001222); Model Catalog: 680 2413 (Lot serial: 56001220); Model Catalog: 680 2413 (Lot serial: 56001229); Model Catalog: 680 2413 (Lot serial: 56001205); Model Catalog: 680 2413 (Lot serial: 56001234); Model Catalog: 680 2413 (Lot serial: 56001231); Model Catalog: 680 2413 (Lot serial: 56001222)
  • Description du dispositif
    VITROS 51 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS