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
    25038
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-11-16
  • 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
    Ortho clinical diagnostics (ocd) has issued this recall due to a software anomaly that may potentially occur on vitros 4600 or 51 fs systems. ocd recently identified that under very specific conditions the temperature in the microwell subsystem (included on vitros 3600 and 5600 systems) may potentially be out of range without the system properly alerting the operator. although vitros 4600 and 51 fs systems do not include a microwell subsystem it utilizes the same software as vitros 3600 and 5600 systems. ocd has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the microslide or microtip subsystems included on vitros 4600 or 51 fs systems.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 680 1375 (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