Events

Rappel de IQ 200 SELECT PLUS

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
    22821
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-14
  • 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
    Iris international has determined that the iq200 series urine microscopy analyzer with barcode reader (model nft-2100) may intermittently exhibit the following: - failure to read the urine sample dilution barcode label where it defaults to a dilution factor of 1:1 and does not apply the correct dilution factor. - failure to read body fluid dilution barcode label where the rack is rejected and no results are generated.

Device

IQ 200 SELECT PLUS
  • Modèle / numéro de série
    Model Catalog: 800-3935 (Lot serial: 8057); Model Catalog: 800-3935 (Lot serial: 8089); Model Catalog: 800-3935 (Lot serial: 8324); Model Catalog: 800-3935 (Lot serial: 5883); Model Catalog: 800-3935 (Lot serial: 5938); Model Catalog: 800-3935 (Lot serial: 5985); Model Catalog: 800-3935 (Lot serial: 6215); Model Catalog: 800-3052 (Lot serial: 6996); Model Catalog: 800-3052 (Lot serial: 9817); Model Catalog: 800-3052 (Lot serial: 3999); Model Catalog: 800-3052 (Lot serial: 7305); Model Catalog: 800-3052 (Lot serial: 7831); Model Catalog: 800-3934 (Lot serial: 6996); Model Catalog: 800-3934 (Lot serial: 9817); Model Catalog: 800-3934 (Lot serial: 7305); Model Catalog: 800-3934 (Lot serial: 7831); Model Catalog: 700-3322 (Lot serial: N/A); Model Catalog: 800-3934 (Lot serial: 3999); Model Catalog: 800-3051 (Lot serial: N/A); Model Catalog: 800-3920 (Lot serial: N/A); Model Catalog: 800-3053 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-3933 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-3
  • Description du dispositif
    IQ 200 SELECT PLUS;IQ 200 ELITE PRO;IQ 200 ELITE PLUS;IQ 200 SPRINT AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 SELECT PRO;IQ 200 ELITE AUTOMATED URINE MICROSCOPY ANALYZER;IQ 200 SPRINT PRO;IQ 200 SPRINT PLUS;IQ200 SELECT URINALYSIS SYSTEM - ANALYZER
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.