Events

Rappel de VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOMERIEUX 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
    28513
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-21
  • 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
    A vitek 2 card pouch integrity issue has been identified for a portion of the card pouches manufactured with raw material white webbing. reports from customers have indicated occurrences of higher-than-expected mic results for imipenem and nitrofurantoin. multiple card types/lots are referenced in the complaints. one of the customers determined via parallel testing that cards contained in white pouches showing visual evidence of a puncture or tear in the pouch at the stitch seal sometimes provided higher mic values than pouches with no evidence of flaw. an investigation was conducted to determine the root cause and scope of the pouch integrity issue. the investigation confirmed that a card pouch defect can allow humidity/moisture to impact the card. moisture sensitivity can lead to antibiotic degradation (loss of potency). this could explain the increased antibiotic resistance experienced by some customers. the investigation determined the root cause was combinations of stitch seal wheel design/positioning on the manufacturing equipment and product shipping/handling. the investigation concluded the card pouch integrity issue potentially impacts 204 card types (504 lots) worldwide.

Device

VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Modèle / numéro de série
    Model Catalog: 413 066 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 063 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 062 (Lot serial: More than 10 contact manuf.); Model Catalog: 412 864 (Lot serial: More than 10 contact manuf.); Model Catalog: 410 028 (Lot serial: More than 10 contact manuf.); Model Catalog: 22233 (Lot serial: More than 10 contact manuf.); Model Catalog: 22226 (Lot serial: More than 10 contact manuf.); Model Catalog: 413402 (Lot serial: 5910280203); Model Catalog: 413404 (Lot serial: 5930287103); Model Catalog: 413404 (Lot serial: 5930279103); Model Catalog: 420 580 (Lot serial: More than 10 contact manuf.); Model Catalog: 415 670 (Lot serial: More than 10 contact manuf.); Model Catalog: 414 971 (Lot serial: More than 10 contact manuf.); Model Catalog: 414 967 (Lot serial: More than 10 contact manuf.); Model Catalog: 413 083 (Lot serial: More than 10 contact manuf.); Model Catalog: 413230 (Lot serial: 1480248203); Model Catalog: 413230 (Lot serial: 14802432
  • Description du dispositif
    VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C;VITEK 2 AST GN71;VITEK 2 AST GN73;VITEK 2 AST XN05;VITEK 2 AST GN67;VITEK 2 AST GN70;VITEK 2 ANC ID;VITEK 2 AST GN48;VITEK 2 AST XN06;VITEK 2 AST N298;VITEK 2 AST GP76;VITEK 2 AST GN86;VITEK 2 AST N223;VIT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.