Events

Rappel de ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) ASSAY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SIEMENS HEALTHCARE LIMITED.

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
    135859
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-03-26
  • 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
    Manufacturer received customer complaints for falsely elevated advia chemistry lipase results as a result of carryover from cholesterol_c dldl and triglycerides reagents. manufacturer internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in high lipase outlier results. the results generated when this issue occurs are falsely elevated for a normal range lipase sample. customers have reported approximately a 25% positive bias while approximately a 12% positive bias was observed in-house. the issue may or may not be detected by quality controls depending on where a carryover incident occurs. if carryover occurs during qc analysis it will impact the qc result. if it does not occur during a qc analysis then the qc result will not be affected.

Device

ADVIA 1200 CHEMISTRY SYSTEM - LIPASE (LIP) ASSAY
  • Modèle / numéro de série
    Model Catalog: B01-4840-01 (Lot serial: ALL); Model Catalog: 01984894 (Lot serial: ALL)
  • Description du dispositif
    ADVIA 1200 CHEMISTRY SYSTEM-LIPASE (LIP) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Adresse du fabricant
    OAKVILLE
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    HC