Events

Rappel de COULTER GEN*S SLIDESTAINER

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
    149508
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-02-17
  • 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
    Beckman coulter has identified the following four (4) issues with the products: issue 1:there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #@[]`{|}~ are substituted or omitted in other languages. the issue affects the gens lh750 lh780 lh500 and dxh 800. issue 2:independent of language the dxh 800 omits the characters *?" when used as part of the selected demographics including specimen id and patient id. issue 3:in the dxh 800 space(s) used as leading character(s) in a patient or specimen id can cause random insertion of extra character(s) within that identifier. issue 4:the lh500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner.

Device

COULTER GEN*S SLIDESTAINER
  • Modèle / numéro de série
    Model Catalog: 6605470 (Lot serial: ALL); Model Catalog: 6605681 (Lot serial: ALL); Model Catalog: 178833 (Lot serial: ALL); Model Catalog: 6605360 (Lot serial: ALL); Model Catalog: 629029 (Lot serial: ALL); Model Catalog: 723585 (Lot serial: ALL); Model Catalog: 6605632 (Lot serial: ALL)
  • Description du dispositif
    COULTER GEN*S SLIDESTAINER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.