Events

Rappel de PREPSTAIN - SLIDE PROCESSOR

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
    56247
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-09-04
  • 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 software issue which may affect bd prepstain slide processors running one of the following software versions: - gyn 1.2 and non-gyn 2.80 - gyn 1.3.0.1 and non-gyn 2.80 rack layout data for software version non-gyn 2.80 are incorrectly reset when gyn software version gyn 1.2 or 1.3.0.1 are subsequently installed on the system. this will result in a loss of chain of custody for non-gynecological samples. when the issue occurs the first 12 samples are not processed at all and all others (up to 36 per run) are deposited on the wrong slide. the risk is highest for customers who have software version gyn 1.3.0.1 (released in june 2008). it is also possible that the issue could occur with software version gyn 1.2 (released in october 2005). there is no impact to gynecological specimen processing (pap tests). in september 2008 all customers using the bd prepstain slide processor were made aware of this software issue and informed that the error may have potentially resulted in mismatched patient results. a process was initiated and is still ongoing to upgrade software for affected customers. bd-canada field service personnel will be upgrading (or have already upgraded) all bd prepstain slide processors to unaffected software versions (gyn 1.3.0.2 or gyn 1.3.0.3).

Device

PREPSTAIN - SLIDE PROCESSOR
  • Modèle / numéro de série
    Model Catalog: 799-13000-00 (Lot serial: All); Model Catalog: 799-14000-00 (Lot serial: All); Model Catalog: 490407 (Lot serial: All)
  • Description du dispositif
    BD PrepStain Slide Processor
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.