Events

Rappel de BBL MGIT MYCROBACTERIA GROWTH INDICATOR TUBE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON CANADA 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
    26656
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-09-16
  • 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
    Product contained incorrect barcodes where the labels began with "43 02" rather than the required "43 01". these batches were placed on quality notification and dispositioned for rework to over-label the barcode area with the correct symbology. the over-label was manually applied to each tube. one customer complaint was received where the over-label had partially peeled off of the tube the incorrect barcode underneath was scanned into the mgit instrument and the epicenter connected to the customer's laboratory system incurred an error. the customer also noted that they found additional tubes in their shipment that had multiple labels or no over-label. the label prefix specifically the 3rd and 4th digits that indicate the media type gives the instrument information for what algorithm to apply for growth detection. growth detection testing will be performed by the mgit instrument every 60 minutes as usual on tubes containing incorrect barcode prefixes but will not flag as positive when growth is visible because media type "43 02" is not defined. a barcode overlabel peeling off exposing an incorrect barcode causes mgit false negative results by not flagging positive tubes. susceptibility tests are not affected since susceptibility testing is conducted in a carrier where instrument instruction is provided by the carrier.

Device

BBL MGIT MYCROBACTERIA GROWTH INDICATOR TUBE
  • Modèle / numéro de série
    Model Catalog: 245122 (Lot serial: 3053240); Model Catalog: 245122 (Lot serial: 3061013)
  • Description du dispositif
    BBL MGIT Mycobacteria Growth Indicator Tube
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.