Events

Rappel de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY

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
    44722
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-04
  • 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 customer complaints of a downward drift/shift in quality control results or low quality control results when using vitros chemistry products cocm reagent. this drift/shift will likely be observed within approximately 3-14 days of calibration. patient results may be affected in the same manner. our investigation has shown that recalibration will be initially effective in resolving the issue but that increased calibration frequency may no longer be effective over time. ocd internal testing has confirmed that this issue occurs will all lots of vitros cocm reagent that are within expiration dating. as a result customers are being asked to discontinue using and discard all vitros cocm reagent remaining in their inventory.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - COCM ASSAY
  • Modèle / numéro de série
    Model Catalog: 680 1995 (Lot serial: 1525-10-2901); Model Catalog: 680 1995 (Lot serial: 1525-09-2754); Model Catalog: 680 1995 (Lot serial: 1525-10-3062)
  • Description du dispositif
    VITROS Chemistry Products COCM Reagent
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS