Events

Rappel de UNICEL DXI 600 ACCESS IMMUNOASSAY SYS - INSTRUMENT W/ DUAL GANTRY CLASS 2

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
    145919
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-08-19
  • 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 determined that nonconforming sample probe cables may have been installed on newly manufactured and/or recently serviced unicel dxi instruments. use of a nonconforming sample probe cable can cause a delay in reporting results but will not cause erroneous results. a nonconforming sample probe cable may cause level sense errors. if a level sense error occurs due to a nonconforming cable the test may not start or an in-process test is automatically cancelled.

Device

UNICEL DXI 600 ACCESS IMMUNOASSAY SYS - INSTRUMENT W/ DUAL GANTRY CLASS 2
  • Modèle / numéro de série
    Model Catalog: A71461 (Lot serial: 900359); Model Catalog: 973100 (Lot serial: 601704); Model Catalog: 973100 (Lot serial: 600785); Model Catalog: 973100 (Lot serial: 601257); Model Catalog: 973100 (Lot serial: 600968); Model Catalog: 4771 (Lot serial: 900950); Model Catalog: 4771 (Lot serial: 900613); Model Catalog: A30260 (Lot serial: 900613); Model Catalog: A30260 (Lot serial: 900950); Model Catalog: 4768 (Lot serial: 601704); Model Catalog: 4768 (Lot serial: 600785); Model Catalog: 4768 (Lot serial: 601257); Model Catalog: 4768 (Lot serial: 600968); Model Catalog: 4772 (Lot serial: 900613); Model Catalog: 4773 (Lot serial: 601257); Model Catalog: 4773 (Lot serial: 600785); Model Catalog: 4772 (Lot serial: 900950); Model Catalog: 4773 (Lot serial: 600968); Model Catalog: 4773 (Lot serial: 601704)
  • Description du dispositif
    UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEMS (DL 75053)
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.