Events

Rappel de BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)

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
    18909
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-12-05
  • 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
    N-acetyl cysteine (nac) when administered in therapeutic concentrations in excess of 500 mg/l (for the treatment of acetaminophen overdose) has been recently determined to interfere with assays for the following analytes: enzymatic creatinine osr6x204 cholesterol osr6x16 uric acid osr6x98 lactate osr6x93 and lipase osr6x30. only these assays are affected. nac is an anti-oxidant and can interfere with assays employing trinder chemical pathways i.E. where hydrogen peroxide (h2o2) is formed and subsequenly reacted with aminoantipyrine and an indicator in the presence of a peroxidase as a catalyst. nac interference has been demonstrated to occur to varying degrees depending on the analyte and therefore not all assays employing trinder chemical pathways are affected. nac interference may lead to falsely low results.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)
  • Modèle / numéro de série
    Model Catalog: OSR61204 (Lot serial: ALL LOTS); Model Catalog: OSR6616 (Lot serial: ALL LOTS); Model Catalog: OSR6116 (Lot serial: ALL LOTS); Model Catalog: OSR6216 (Lot serial: ALL LOTS); Model Catalog: OSR6516 (Lot serial: ALL LOTS); Model Catalog: OSR6698 (Lot serial: ALL LOTS); Model Catalog: OSR6298 (Lot serial: ALL LOTS); Model Catalog: OSR6130 (Lot serial: ALL LOTS); Model Catalog: OSR6198 (Lot serial: ALL LOTS); Model Catalog: OSR6098 (Lot serial: ALL LOTS); Model Catalog: OSR6230 (Lot serial: ALL LOTS); Model Catalog: OSR6193 (Lot serial: ALL LOTS)
  • Description du dispositif
    BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - ENZYMATIC CREATININE
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.