Events

Rappel de MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECKMAN COULTER CANADA L.P..

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
    141326
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-06-08
  • 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
    Customers reported receiving lhb broth tubes which visually appeared to be discolored and/or turbid. some of the tubes visually evaluated were confirmed to have been contaminated. the supplier performed retention samples testing for the two affected lots and found no contamination or turbid broth in any of the tubes however beckman coulter is sending notification letters to customers who received affected lots for their awareness. if a contaminated tube were inadvertently used it could result in mis-interpretation of susceptibility.

Device

MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)
  • Modèle / numéro de série
    Model Catalog: B1015-25 (Lot serial: 1003705450); Model Catalog: B1015-25 (Lot serial: 1003730240)
  • Description du dispositif
    MICROSCAN MUELLER-HINTON BROTH WITH 3% LYSED HORSE BLOOD (LHB BROTH)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.