Events

Rappel de CONTOUR NEXT CONTROL SOLUTION (LOW)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAYER INC..

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
    84943
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-05-25
  • 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
    1.Control result not marked as a control test: bayer healthcare has received user reports on contour next control test results that are higher than the control range published on the packaging of contour next test strips and not recognized as control tests by the meter. all lots of contour next control solution (levels low normal and high) are affected. 2.Control result outside of control range: another issue may affect any control solution lots when used with contour next test strip lots with expiration dates through november 2016. due to unforeseen material variation lots of contour next control solution may give control test results that are outside of the assigned control range as published on the packaging of contour next test strips. these control results are properly marked as control tests by the meter therefore this issue does not impact insulin pumps.

Device

CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Modèle / numéro de série
    Model Catalog: 7323 (Lot serial: All lots); Model Catalog: 7325 (Lot serial: All lots); Model Catalog: 7324 (Lot serial: All lots)
  • Description du dispositif
    CONTOUR NEXT CONTROL SOLUTION (LOW)
  • Manufacturer
    BAYER INC.

Manufacturer

BAYER INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    HC