Events

Rappel de UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

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
    22724
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-10-21
  • 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
    Beckman coulter has confirmed 5 issues on the unicel dxht 800 coulter cellular analysis system. issue 1: there is a possible dilution of sample if user requests a diluent dispense while specimens are being processed in cassette presentation resulting in erroneous results. issue 2: cbc: rbc and hct are improperly corrected and not flagged when there is a wbc pump error and the reported wbc > 140/ul. in body fluid (bf) panels: rbc is improperly corrected and not flagged when there is a wbc pump error. issue 3: there is a potential for erroneous retic results when the instrument user interface allows reflex processing of pre-diluted specimen in the retic test panel instead of limiting processing to cbc only. issue 4: there is the potential for body fluid results to be incorrectly interpreted by the laboratory information system. issue 5: sharp edges on the dxh800 reagent cabinet (floor stand) drawer slides may expose operators to physical injury while replacing reagents and waste containers.

Device

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Modèle / numéro de série
    Model Catalog: 629029 (Lot serial: ALL)
  • Description du dispositif
    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.