Events

Rappel de STAGO STA SYSTEM - LIQUID ANTI-XA 4

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

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
    82611
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2014-07-30
  • 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
    The stago hotline/call center has received some customer complaints regarding a misreading of reagent 1 (substrate)barcode on sta analyzers. diagnostica stago has investigated and confirmed that the barcode is incorrectly coded. consequently when the barcode is scanned on sta analyzers the last 3 digits displayed are "066" instead of "366". when the corresponding flyer is scanned the sta analyzer displays an error message because the lot of the vial does not match with the lot on the flyer. it is a labelling issue however the defect is only in the barcode the lot number 112366 printed on the vial is correct.

Device

STAGO STA SYSTEM - LIQUID ANTI-XA 4

Manufacturer

STAGO CANADA LTD./STAGO CANADA LTEE