Events

Rappel de VITROS 3600 IMMUNODIAGNOSTIC 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
    58440
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-05-13
  • 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 received several reports of condition codes that occurred during the calibration of microwell assays. internal investigation determined that the microwell shuttle weight on some vitros systems may be uncoated and therefore out of our manufacturing specifications. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is not performed biased results could potentially occur. internal testing determined that quality control results using an uncoated well weight showed on average a 10% shift from established means that was within the quality control ranges. the magnitude of the bias is not likely to impact patient safety.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Modèle / numéro de série
    Model Catalog: 6802783 (Lot serial: 36000627); Model Catalog: 6802783 (Lot serial: 36000264); Model Catalog: 6802783 (Lot serial: 36000130); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Description du dispositif
    VITROS 3600 Immunodiagnostic System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS