Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT

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
    78223
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-02-19
  • 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 determined that extension springs on some vitros systems may be out of the manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in our manufacturing facility it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. our evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. to date ocd has not received any customer complaints related to this issue.

Device

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

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS